SARTHAK BIOTECH PVT
SARTHAK BIOTECH Pvt. Ltd.
198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE
INDEX OF PRODUCTION SOPS
Sr. NoName of the SOPCategory/SOP No.Rmk
1.SOP FOR Preparation of Sanitizing SolutionSPD/01
2.SOP FOR Rodents, Insects & Birds Control in
ProductionSPD/02
3.SOP FOR Cleaning and Operation of Air Handling Unit Pre
FiltersSPD/03
4.SOP FOR Disposal of Expired Finished GoodsSPD/04
5.SOP FOR Building MaintenanceSPD/05
6.SOP FOR Disposal of ExceSs/ Rejected Packing
MaterialSPD/06
7.SOP for Entry/ Exit of Visitors in Manufacturing
AreaSPD/07
8.SOP for Entry into Production AreaSPD/08
9.SOP for Safety PracticesSPD/09
10.SOP for Log Book SystemSPD/10
11.SOP for Environment MonitoringSPD/11
12.SOP FOR Removal of Scrap from Production AreaSPD/12
13.SOP FOR Disposal of Empty ContainersSPD/13
14.SOP FOR Cleaning of General DressesSPD/14
15.SOP for Cleaning and Sanitation of General area production
blockSPD/15
16.SOP FOR Calibration and Operation of Weighing
BalanceSPD/16
17.SOP FOR Cleaning and Operation of Manual Capsule Filling
MachineSPD/17
18.SOP FOR Cleaning and Operation of Blister Packing
MachineSPD/18
19.SOP FOR Cleaning and Operation of Double Cone
BlenderSPD/19
20.SOP FOR Cleaning and Operation of Dry Filling
MachineSPD/20
21.SOP FOR Cleaning and Operation of ROPP Cap Bottle Sealing
MachineSPD/21
22.SOP FOR Decartoning of Containers and ClosuresSPD/22
23.SOP FOR Controlling Microbial Contamination (Ointment
Section)SPD/23
24.SOP FOR Procedure for Line Clearance ( Packing)SPD/24
25.SOP FOR Visual InspectionSPD/25
26.SOP FOR Batch CodingSPD/26
27.SOP FOR Reprocessing of RecoverySPD/27
28.SOP FOR Leak Test for Capsules/ Tablets (Strip and Blister
Packing)SPD/28
29.SOP FOR Cleaning & Operation of Capsule LoaderSPD/29
30.SOP FOR Cleaning & Operation of DehumidifierSPD/30
31.SOP FOR Cleaning & Operation of Strip Packing
MachineSPD/31
32.SOP FOR Cleaning & Operation of SifterSPD/32
33.SOP FOR Handling of Finished Products in StoreSPD/33
34.SOP FOR Packing OperationSPD/34
35.SOP for Cleaning of Paste KettleSPD/35
36.SOP for General Cleaning of Equipment in Manufacturing
AreaSPD/36
37.SOP for Adverse Health Condition of person in Manufacturing
AreaSPD/37
38SOP for Internal Labeling during Quarantine, Storage and
Processing SPD/38
39.SOP for receipt of Packing Material in ProductionSPD/39
40.SOP for Disposal & Salvage of Rejected / Expired /
Unusable MaterialSSPD/40
41.SOP for the Waste Collection from Production AREASPD/41
42.SOP FOR Cleaning of Conventional Coating PanSPD/42
43.SOP FOR Cleaning of Fluidized Bed DryerSPD/43
44.SOP FOR Cleaning AND OPERATION of MultimillSPD/44
45.SOP FOR Cleaning of Polishing PanSPD/45
46.SOP FOR Cleaning and Operation of Capsule Filling Machine
(SEMI AUTO MATIC)SPD/46
47.SOP FOR Cleaning of Spray GunSPD/47
48.SOP FOR Cleaning of TableT DepartmentSPD/48
49.SOP FOR Paste Preparation VesselSPD/49
50.SOP FOR Disposal Operation in Tablet DepartmentSPD/50
51.SOP FOR Cleaning & Assembling of Compression Machine
SPD/51
52.SOP FOR Tablet Compression ToolingSPD/52
53.SOP FOR Storage of In-process Tablets &
GranulesSPD/53
54.SOP FOR Operation of Fluidized Bed DryerSPD/54
55.SOP FOR Cleaning AND OPERATION of Mass MixerSPD/55
56.SOP FOR Tablets InspectionSPD/56
57.SOP FOR House Keeping in Tablet Compression SECTIONSPD/57
58.SOP FOR House Keeping in Tablet Packing AreaSPD/58
59.SOP FOR Cleaning of Manufacturing Vessel (Topical
Section)SPD/59
60.SOP FOR Cleaning of Bulk Tank (Topical Section)SPD/60
61.SOP FOR Cleaning and Assembling of Tube Filling Machine
(Topical Section)SPD/61
62.SOP FOR Polishing of CapsulesSPD/62
63.SOP FOR Cleaning of S.S. Wax Melting Vessel (Topical
Section)SPD/63
64.SOP FOR Polishing of Punches and DiesSPD/64
65.SOP FOR Cleaning of Utensils, Scrapper,SPOONS & Scoops
(Topical Section)SPD/65
66.SOP FOR Removal of Bulk from Tube Filling Machine (Topical
Section)SPD/66
67.SOP FOR In-Process Control IN Manufacturing (Topical
Section)SPD/67
68.SOP FOR House Keeping IN Topical SectionSPD/68
69.SOP FOR Installation of New Punch SetSPD/69
70.SOP FOR In-Process Packing ( Topical Section)SPD/70
71.SOP FOR Line Clearance (Topical Section)SPD/71
72.SOP FOR Cleaning of S.S. Water Vessel (Topical
Section)SPD/72
73.SOP FOR In-Process Fill Weight DeterminationSPD/73
74.SOP FOR LABELLING & PACKING OF ORAL LIQUIDSPD/74
75.SOP FOR CLEANING OF GENERAL UTENSILS, SS CONTAINERSSPD/75
76.SOP FOR CLEANING OF MANUFACTUIRNG AREA (TABLET, CAPSULE &
LIQUID ORALS)SPD/76
77.SOP FOR CLEANING OF S.S. CONTAINERS, PRESSURE VESSELS, S.S.
TANKS & STIRRERSPD/77
78.SOP FOR CLEANING OF CONVEYOR BELTSPD/78
79.SOP FOR OPERATION & CLEANING OF BOTTLE FILLING
MACHINESPD/79
80.SOP FOR OPERATION & CLEANING OF BOTTLE WASHING MACHINE
SPD/80
81.SOP FOR OPERATION & CLEANING OF COLLOIDAL MILLSPD/81
82.SOP FOR OPERATION & CLEANING OF HIGH SPEED
STIRRERSPD/82
83.SOP FOR OPERATION & CLEANING OF FILTER PRESSSPD/83
84.SOP FOR OPERATION & CLEANING OF PP CAP SEALING
MACHINESPD/84
85.SOP FOR VISUAL INSPECTION OF LIQUID ORALSSPD/85
86.SOP FOR CLEANING OF S.S. TANKS & STIRRER (LIQUID
SECTION)SPD/86
87.SOP FOR MIXING, GRANULATION & PUNCHINGSPD/87
88.SOP FOR STRIP VISUAL INSPECTIONSPD/88
89.SOP FOR OPERATION AND CLEANING OF TABLET COMPRESSION MACHINE
(ROTARY MACHINE)SPD/89
90.SOP FOR OPERATION AND CLEANING OF TABLET COMPRESSION MACHINE
(MULTI PUNCHING MACHINE)SPD/90
91.SOP FOR OPERATION OF TUBE FILLING , SEALING ,CLEANING,
CRIMPING & BATCH CODING MACHINE (TOPICAL SECTION)spd/91
92.SOP FOR INSPECTION, CLEANING & PACKING OF TUBESSPD/92
93.SOP FOR BATCH DESTRUCTIONSPD/93
94.SOP FOR CLEANING & OPERATION OF PLANETARY MIXERSPD/94
95.SOP FOR CLEANING, OPERATION & MAINTENANCE OF COLLOIDAL
MILL.SPD/95
96.SOP FOR WASHING & CLEANING OF EQUIPMENTS (EXTERNAL
PREPARATION SECTION)SPD/96
97.SOP FOR BATCH PREPARATION OF EXTERNAL PREPARATIONSPD/97
98.SOP FOR WASHING, CLEANING & STORAGE OF EQUIPMENT,
VESSELS, & STIRRER MACHINE PARTS FOR OINTMENT &
CREAM.SPD/98
99.SOP FOR COATING PANSPD/99
100.SOP FOR TRANSFER OF FINISHED GOODS TO FINISHED GOODS
STORESPD/100
101.SOP FOR OPERATION AND CLEANING OF TRAY DRIERSPD/101
102.SOP FOR OPERATION AND CLEANING OF ALU-ALU PACK
MACHINESPD/102
103.SOP FOR OPERATING OF AIR COMPRESSORSPD/103
104.SOP FOR OVER PRINTING ON STRIPSSPD/104
105.SOP FOR LEAKAGE CHECKS IN FILLED BOTTLESPD/105
106.SOP FOR OVER PRINTING ON BOXES AND LABELSSPD/106
TITLE: SOP FOR PREPARATION OF SANITIZING SOLUTIONPage : 01-02
Deptt.: PRODUCTION
SOP NO. : SPD/01Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:Asstt. Production ChemistChecked By:Production
ManagerApproved By
Q.A. ManagerDirector
Sign.Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Preparation of Sanitizing
Solution.2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:
5.1 Preparation of Sanitizing Solution5.1.170% Isopropyl Alcohol
in D. M. water.Take 700ml IPA in a measuring cylinder. Add
sufficient quantity of D.M.water to make 1.0-Liter solution.
5.1.22% Savlon solution in D.M water.Take 20ml Savlon Solution
in a measuring cylinder and make 1.0 liter using DM water.5.1.3 2%
Dettol solution in D M waterTake 20ml Dettol Solution in a
measuring cylinder and make 1.0 liter using DM water.5.1.45% Phenol
solution in DM water.
Heat the bottle containing Phenol in a water bath till it
melts.Take 50ml liquified Phenol in a measuring cylinder and make
volume up to 1.0 liters by using DM water.
TITLE: SOP FOR PREPARATION OF SANITIZING SOLUTIONPage :
02-02
Deptt.: PRODUCTION
SOP NO. : SPD/01Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign.Sign..Sign....Sign...
5.1.54% v/v Hydrogen Peroxide solution in Distilled waterTake 40
ml Hydrogen Peroxide in a measuring cylinder and add distilled
water to it to make up the volume 1.0 liters.
5.1.6 2% v/v Benzalkonium Chloride solution in Distilled
waterTake 20ml Benzalkonium Chloride in a measuring cylinder and
add distilled water to it to make up the volume 1.0 liters.
5.1.7 2% v/v Glyceraldehyde solution in Distilled water
Take 20ml Glyceraldehyde in a measuring cylinder and add
distilled water to make volume 1.0 liters.Note: All these
preparations are prepared in third air lock.
5.2 Precaution: Wear Gloves, Mask & Goggles before preparing
sanitizing solution.TITLE: SOP FOR RODENTS, INSECTS & BIRDS
CONTROL IN PRODUCTIONPage : 01-01
Deptt.: PRODUCTION
SOP NO.: SPD/02Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign.Sign..Sign.......Sign...
1) PURPOSE: To lay down procedure of control of rodents, insects
and birds to be carried out by the approved contractor.
2) RESPONSIBILITY: Q.A. Manager
3) ACCOUNTABILITY: Production Manager/ Q A Manager.
4) SCOPE: The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5) PROCEDURE:
5.1 The approved contractor is deputing for control of birds,
redents and insects by applying the chemical. Birds repellents,
nets sieves repellents i.e. UV repellent (blue light), flycatcher,
door nets are fixe on all entries. For insect control, company has
placed at all the entry-exit place, double door, one with wire
mesh, other with wooden & glass doors, with the facility of
door closer.
5.2 Entries doors are installe with are Curtains to avoid entry
of insects.5.3 The contractor come twice every month or whenever
called to review the situation.
TITLE: SOP FOR CLEANING & OPERATION OF AIR HANDLING UNIT PRE
FILTERSPage : 01-01
Deptt.: PRODUCTION
SOP NO.: SPD/03Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign...Sign..Sign....Sign...
1 PURPOSE:To lay down a Procedure for Cleaning and Operation of
Air Handling Unit Pre-Filters.
2 RESPONSIBILITY:Q/C Manager.
3 ACCOUNTABILITY:Production Manager/Q.A. Manager
4 SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5
PROCEDURE:
5.1 Cleaning of pre-filter 20 micron average 7-15 days i.e.
.weakly off day.
5.2 Cleaning of pre-filter cabinet is carried out side of the
production area.
1) CLEANING:6.1 Before cleaning of the AHU pre-filter, switch
OFF the mains.
6.2 Loosen the filter cabinet bolts.
6.3 Remove the filter cabinet set aside.
6.4 Close the AHU filter cabinet with poly bag till the filter
is ready to be fixed.
6.5 Clear the filter by compressed air at least for five times
with airflow in reverse of the operational flow direction, out side
the production area.
6.6 Wash the pre-filters using mild soap solution and then with
running tap water.
6.7 Pass the compressed air through the other side of the filter
and then dry the filter.
6.8 Remove the poly bag from dust.
6.9 Clean the filter cabinet with dry clothes.
6.10 Fix the pre-filter and tight cabinet bolts.
6.11 Record the cleaning operation of pre-filters in prescribed
format.TITLE: SOP FOR DISPOSAL OF EXPIRED FINISHED GOODSPage :
01-01
Deptt.: PRODUCTION
SOP NO.: SPD/04Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign....Sign....Sign...
6) PURPOSE:To lay down a Procedure for Disposal of Expired
Finished Goods.
7) RESPONSIBILITY:Q/C Manager.
8) ACCOUNTABILITY:Production Manager/Q.A. Manager
9) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.10)
PROCEDURE:
5.1 All the finished goods are carried to the disposal area in
the final packed form. Take out the inner carton from the shipper
& finally take out the Tablets/ Capsules/ Oral Liquid/ Dry
Syrup & Ointment from the inner cartons.
5.2 In case of Tablets/ Capsules/ Oral Liquid/ Dry Syrup &
Ointment, submerge them in water to dissolve & after
dissolution, dump the slurry or solution into a ditch. In case of
Oral Liquid, break the seal of bottles, take out the liquid or
solution into a bucket & put it into the ditch. Glass
containers & seals are kept separately for sale as a waste.
Shippers & inner cartons are burnt separately during packing
material disposal.
5.3 The label of the labeled bottle is removed before
disposal.
1) PRECAUTIONS :
6.1 Expired finished materials are not used for medicinal
purpose.
6.2 Cartons or shipper or poly bags in which the finished
materials were kept are separated before disposal of finished goods
and disposed off separately.
6.3 Disposal done under supervision of Q.A. Head.
6.4 Poisonous or obnoxious materials are treated to
neutralization before dumping.
6.5 After disposal of the material, the same is recorded.
TITLE: SOP FOR BUILDING MAINTENANCEPage : 01-02
Deptt.: PRODUCTION
SOP NO.: SPD/05Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign.Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Building Maintenance.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:
5.1 The factory maintenance is an important part of maintaining
facilities to work smoothly and hygienically and periodically
maintained by repairing, painting, washing, moping etc.
5.2 MAINTENANCE REQUIRED :
The following categories of the maintenance are generally
required in a Pharmaceutical formulation plant.
5.2.1 Civil Maintenance
5.2.2 Electrical Maintenance
5.2.3 Utilities Maintenance
The above categories are further classified as under to
decentralize the work according to need.
5.2.1 CIVIL MAINTENANCE:This includes the following parts of
maintenance in a building.
5.2.1.1 Repairs of walls and floors with plastering work.
5.2.1.2 Parts on walls and other places where ever required.
5.2.1.3 Aluminum or glass work required for doors and
windows.
5.2.1.4 External roads linked with the Production premises.
5.2.1.5 Insects/ Rodents protective mesh where ever
provided.
TITLE: SOP FOR BUILDING MAINTENANCEPage : 02-02
Deptt.: PRODUCTION
SOP NO.: SPD/05Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign.Sign..Sign....Sign...
5.2.2. ELECTRICAL MAINTENANCE:5.2.2.1 Exhaust fans, Fans, Air
Conditioners.
5.2.2.2 Tube lights, Insect repeller, Air curtain.
5.2.2.3 General wiring of Production premises and electrical
points.
5.2.2.4 Electrical water purification system where ever
applicable.
5.2.2.5 Major electrical panels.
5.2.3 UTILITIES MAINTENANCE:5.2.3.1 Cleaning and maintenance of
water distribution system.
5.2.3.2 Maintenance of drainage system, sinks, taps, pipes.
5.2.3.3 Maintenance of air cooling system.
5.2.3.4 Maintenance of effluent treatment plant.
5.2.3.5 Generator system and transformer.
5.2.3.6 Lawns and plantation maintenance.
1) FREQUENCY6.1 All major repairs of production premises: Once
in 6 months.
6.2 Paints: Once in 6 months in those areas where repair has
been done.
Once in a year for the complete plant & factory.
6.3 For Doors and glass work: Once in 2 months.
6.4 For wire mesh: Once in 6 months.
6.5 For external roads: Once in a year.
2) MAINTENANCE PROCEDURE:7.1 The maintenance carried out when
the production is not going on.
7.2 All electrical maintenance work to be done by an expert
under the supervision of Companys Electrical Engineer.
7.3 All repairs are carried out on request of the concerned
Department Head in writing and approval by the above referred
authorized persons.
7.4 Records and log for all such repairs are maintained.TITLE:
SOP FOR DISPOSAL OF EXCESS / REJECTED PACKING MATERIALPage :
01-01
Deptt.: PRODUCTION
SOP NO.: SPD/06Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign...Sign...Sign....Sign...
1) PURPOSE:To lay down a Procedure for Disposal of Excess /
Rejected Packing Material.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:
5.1 After completion of packing operation of one batch product,
the packing line is checked for excess packing materials.
5.2 Excess P.M. sorted out and good / without printed packing
materials is counted and tied.
5.3 All good material are returned to packing material store
through material return note.
5.4 All coded unit cartons/labels are transferred to scrap yard
and shredded into pieces before disposing off.
5.5 Details of all returned materials and rejected materials are
recorded in packing material reconciliation sheet included in Batch
Production Record.
TITLE: SOP FOR ENTRY/EXIT OF VISITORS IN MANUFACTURING AREAPage
: 01-01
Deptt.: PRODUCTION
SOP NO.: SPD/07Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Entry / Exit of Visitors
in Manufacturing Area.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:Entry of Visitors: -
5.1 Entry of visitor to these Areas is restricted as much as
possible.
5.2 Entry of visitors is given a clean lab coat, cap &
mask.
5.3 Then visitors & accompanying authorized person put shoe
cover on his street shoes or wear clean laboratory sleepers. They
cross the barrier before entering manufacturing area. After which
they are dip the footwears in to the disinfecting solution soaked
mat and then into the main working area.
5.4 Before leaving the manufacturing area visitor remove the
shoe cover, lab coat, cap & mask and the concerned officer send
them for washing.
TITLE: SOP FOR ENTRY INTO PRODUCTION AREAPage : 01-01
Deptt.: PRODUCTION
SOP NO.: SPD/08Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign.Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Entry into Production
Area.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:Before entering into any area the following norms are
followed: -5.1 Wash and dry their hands.
5.2 Wear clean factory uniform, head covers, gloves, masks and
foot-covers where necessary.
5.3 Workman wears head cover, facemask in such a way that the
whole head, hair, moustaches and beards are covered so that
particles on the hair do not contaminate the working areas.
5.4 Outside visitors when taken for a round in the operational
areas should wear aprons, head-covers and foot-covers as per the
requirement.
5.5 Before changing into factory uniforms, items of jewellary is
removed and kept in the lockers provided.
5.6 No food or drink is carried in the production areas.
5.7 Do not eat; chew tobacco, pan or betel nuts while
working.
5.8 Smoking is strictly prohibited in the production areas/
office premises.
5.9 Nails are trimmed frequently.
5.10 Use of cosmetics and perfumes are avoided as far as
possible.TITLE: SOP FOR SAFETY PRACTICESPage : 01-01
Deptt.: PRODUCTION
SOP NO.: SPD/09Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Safety Practices.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:
5.1 Hand gloves and safety shoes are used in the manufacturing
area. Enough, gloves, etc. are available and used when
required.
5.2 Lighting and electrical fittings are flame proof. In case of
hot work, there is a system to issue welding and fire permit (spark
generating maintenance activity).
5.3 All safety precautions are adopted according to the
needs.
TITLE: SOP FOR LOG BOOK SYSTEMPage : 01-02Deptt.: PRODUCTION
SOP NO.: SPD/10Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Log Book System.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:FORMAT: Log-book is maintained depending upon the user
department, the log book should contain the following details:5.1
Equipment:a) Name of Equipment.
b) Code No.
c) Product & its batch number.
d) Remarks, if any
e) Signature of chemist and Signature of the person
checking.
5.2Lab Instrument:a) Instrument Name
b) Sr. No.
c) Date of Analysis
d) Analysis time
e) Product analyzed & its batch number
f) A.R. No.
g) Remarks of Analysis if any
h) Signature of analyst and Signature of the person checking the
analysis report.TITLE: SOP FOR LOG BOOK SYSTEMPage : 02-02
Deptt.: PRODUCTION
SOP NO.: SPD/10Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
5.3Chemist / Analysts Log Book:a)Date of analysis
b)Name of the test, analysis data and calculation details.
c)Product analyzed & its batch number
d)Signature of analyst and Signature of the person checking the
analysis.
5.4Calibration Log Books:
a)Instrument Name
b)Range
c)Accuracy
d)The standard used
e)Calibration Frequency
f)Model No.
g)Signature of person calibrating the equipment / instrument and
Signature of the person reviewing the calibration report.Note: If
any instrument is malfunctioning or requires non-routine
maintenance, work order should be generated by the Analyst /
Chemist responsible for calibration of that instrument and
maintenance details to be entered in instrument log book / chemist
log book.
Equipment / Instrument Name
Service required data
Data repaired
Nature of repair work carried out in detail
Re-calibration data
Signature of chemist and dateTITLE: SOP FOR ENVIRONMENT
MONITORINGPage : 01-03
Deptt.: PRODUCTION
SOP NO.: SPD/11Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Environment
Monitoring.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:
5.1 Record the temperature & humidity in the environment
monitoring chart.
5.2 Regulate the A/C of Dehumidifier if the temperature of a
particular area is the out of the prescribed limit.
5.3 The limit is specified below:
AreaTemperatureHumidity
Mixing Granulation & Drying28-29O C70% Max.
Blending, Compression25-27O C40-45%
Capsulation, Powder, Dry Syrup23-25O C40-45%
Beta-Lactum Capsules, Tablets23-27O C40-45%
Film Coating25-27O C50-55%Corridors25-27O C70% MaxTITLE: SOP FOR
ENVIRONMENT MONITORINGPage : 02-03
Deptt.: PRODUCTION
SOP NO.: SPD/11Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
(a)Store area for
Beta Lactum
25-27O C50% Max
Capsules & Sensitive Materials25-27O C50% Max
Other products
30O C
70% Max
(b) Laboratory
Instrument room & Microbiology room25-27O C50% Max
Chemical Laboratory
28-30O C70% Max
Quarantine & Control Sample Room
25-27O C50% Max
Liquid Mfg. & Bottle Washing
28-29O C70% Max
Ointment & Lotions
25-27O C50-55%
TITLE: SOP FOR ENVIRONMENT MONITORINGPage : 03-03
Deptt.: PRODUCTION
SOP NO.: SPD/11Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1. Record the result in the following
formatDateAreaTimeLimitObservationRemarks
TITLE: SOP FOR REMOVAL OF SCRAP FROM PRODUCTION AREAPage :
01-01
Deptt.: PRODUCTION
SOP NO.: SPD/12Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Removal of Scrap form
Production Area.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:5.1 All the scraps are collected in a polythene lined
dust bin.
5.2 All scarp filled polythene bags in dustbin are taken to
scrap dumping area.
6) PRECAUTIONS:
6.1All scraps must be checked by House keeping Supervisor to
ensure that no printed packing material container or machine parts
reach at the backyard.
TITLE: SOP FOR DISPOSAL OF EMPTY CONTAINERSPage : 01-01
Deptt.: PRODUCTION
SOP NO.: SPD/13Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
7) PURPOSE:To lay down a Procedure for Disposal of Empty
Containers.
8) RESPONSIBILITY:Q/C Manager.
9) ACCOUNTABILITY:Production Manager/Q.A. Manager
10) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.11)
PROCEDURE:5.1 CORRUGATED BOXES
5.1.1 Ensure that the boxes/ containers are empty.
5.1.2 Fold the boxes, stuck and tie them.
5.1.3 Transfer them to scrap yard.
5.2 METALLIC CONTAINERS
5.2.1 Wash all the containers with sufficient quantity of tap
water.
5.2.2 Transfer the containers to scrap yard.5.3 GLASS
CONTAINERS
5.3.1 The glass scarp is sorted out in the Scarp Yard.
5.3.2 Containers are property checked for any left out
material.
5.3.3 Cross mark on label of the corrugated box with black
marking pan.
5.3.4 Do not use empty containers for storage of any other
material.
5.3.5 Destroy the containers containing hazardous / corrosive
material in presence of warehouse supervisor.TITLE: SOP FOR
CLEANING OF GENERAL DRESSESPage : 01-02
Deptt.: PRODUCTION
SOP NO.: SPD/14Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Cleaning of General
Dresses.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:All the dresses are cleaned at a single place under the
supervision of the above-specified competent personnel.5.1 The
collected dresses are further categorized as per their color and
utilization and properly recorded in the log book available with
the house keeping department.
5.2 All the unclean dresses are then segregated as per their
color and use and entered in the log book prior to given for
washing.
1) CLEANING PROCEDURE :6.1 The unclean dresses are washed by the
washerman; he is instructed to wash colored and white dresses
separately to avoid coloration of the white dresses.
6.2 The dresses are first observed for any oil spot or other
chemicals to be removed with solvent namely IPA / Ethanol, prior to
washing.
6.3 The above treated dresses are then dipped in a soap solution
at a temperature between 40 to 45OC and rotated for 30 to 35
minutes.TITLE: SOP FOR CLEANING OF GENERAL DRESSESPage : 02-02
Deptt.: PRODUCTION
SOP NO.: SPD/14Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
6.4 The above treated dresses are then squeezed and dipped in a
drum of fresh water and again rotated for 30 minutes and with
another change of fresh water these are placed for spinning
stage.
6.5 Drying of the washed dresses are carried either by
centrifugal method of by drying in a current of warm air. Drying in
direct sunlight is strictly avoided.
6.6 After complete drying of the dresses it goes under
ironing.
6.7 The dresses are daily cleaning as per the above
procedure.
6.8 All the cleaned dresses are then received and recorded in
the Logbook.
6.9 The cleaned dresses are then segregated as per their colour
and requirements and kept in the appropriate cupboard making entry
in the logbook.
6.10 The above cycle is continuously monitored and dresses are
issued to each department by Signing in the logbook.
6.11 The change in the above process is validated by the
concerned Department / Personnel only.TITLE: SOP FOR CLEANING AND
SANITATION OF GENERAL AREA PRODUCTION BLOCKPage : 01-03
Deptt.: PRODUCTION
SOP NO.: SPD/15Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Removal of Scrap form
Production Area.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
FREQUENCY:Daily Schedule.
6) PROCEDURE:6.1 Pick up the trace materials from floors.
6.2 Empty waste bins and reline with plastic bags when
necessary.
6.3 Wash sink and waste pipe using 0.1% Teepol solution in water
and wipe dry.
6.4 Wash interior surface of commode bowl using bowl cleaner
solution with a bowl mop. Wash exterior surface of bowl seat using
0.1% Teepol solution in water.
6.5 Damp mop all accessible are using lint free or rubber lined
handle mops initially with a 0.1% Teepol solution in water then
with plain water and finally with a disinfectant solution.
Bucket 1 To squeeze out the dirty water from mop.
Bucket 2- To Contain clean water for rinsing the mop.
6.6 Use two bucket system.
6.7 Dispose off the used water promptly.
6.8 Allow the floor to dry up.
6.9 Flush out the drainage channel after removing any solid
debris.TITLE: SOP FOR CLEANING AND SANITATION OF GENERAL AREA
PRODUCTION BLOCKPage : 02-03
Deptt.: PRODUCTION
SOP NO.: SPD/15Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
6.10 Wipe the surrounding area with a mop soaked in disinfectant
solution.
6.11 Wash hands before carrying out any other activities.
6.12 Rotate the disinfectant to be used on daily basis and
record the same in daily cleaning.
6.13 Mop up any spillages as soon as it occurs.
6.14 Carryout the cleaning operation as and when necessary to
ensure the aera as clean and hygienic.
6.15 Fill the daily cleaning and sanitation record and get it
Signed.
Weekly Schedule:1. Clean the wall using sponge impregnated with
0.1% Teepol solution in water.
2. Wipe down the handrails, stairways with an approved
disinfectant solution.
3. Dedust all the shelves, floors and walls of change rooms, the
storage and weighting area using a sponge.
4. Damp wipe all surfaces with 0.1% Teepol solutions in water
after moving out any movable equipment such as container, weighing
balance.
5. Damp wipe the accessible parts of intercom with sponge or
cloth.
6. Damp wipe the doors, push plates, view panels and glasses
with a spray of aerosols cleaner (Colin) and wipe dry.
7. Dedust exhaust fan, light fixer with sponge or cloth.
8. Damp wipe all other fixer with a sponge or cloth using 0.1%
Teepol solution in water.
9. Hose down the passages with plenty of water. Flush out the
water.TITLE: SOP FOR CLEANING AND SANITATION OF GENERAL AREA
PRODUCTION BLOCKPage : 03-03
Deptt.: PRODUCTION
SOP NO.: SPD/15Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
Monthly Schedule
1) Wash waste bin with a disinfectant solution.
2) Apply the floor finish on clean and dry floor and rub it to
polish.
3) Clean wipe the light diffuser and U.V. Light tube with a wet
cloth.
4) Clean wipe the light switches with I.P.A.
TITLE: SOP FOR CALIBRATION AND OPERATION OF WEIGHING BALANCEPage
: 01-02
Deptt.: PRODUCTION
SOP No.: SPD/16Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Calibration and Operation
of Weighing Balance.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:
6) CALIBRATION :6.1 Switch off the electric supply to the
balance, in case of an electric balance.
6.2 Clean the pan/ platform of the balance with a brush. If
required cleaning is done with clean cloth dipped in 0.1% Teepol
solution followed by clean water.
6.3 Check the level of balance and ensure that the balance is
properly leveled.
6.4 Select the standard weights for various weighing balance
based upon the capacity of balance to be calibrated.
6.5 In case of electronic balance switch ON the balance, adjust
the balance whether electronic or mechanical to zero. Place
standard weight s one by one on the platform/ pan. Record the
rading in respect calibration record. These records are available
at weighing station.
6.6 Check that the observed weights are within the limits, as
given in this SOP.
6.7 If the error is more than acceptable limits, the error is
rectified before the balance is to be used.
6.8 Do not use the balance if the error is not rectified. Inform
the Production Executive and call the Service Engineer.Balance
CapacityStandard WeightStandard WeightAcceptable Limit
200 gm1.00 gm10 gm+0.1 % max.
6 kg400 gm5 kg.+0.25% max.
60 kg5 kg.10 kg.+0.25% max.
100 kg5 kg.50 kg.+0.25% max.
TITLE: SOP FOR CALIBRATION AND OPERATION OF WEIGHING BALANCEPage
: 02-02
Deptt.: PRODUCTION
SOP No.: SPD/16Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
6.9 Selection of standard weights for interpretation of data is
given below :-7.0 OPERATION:-7.1 In case of electronic balance,
switch OFF electric supply to the balance.
7.2 Clean the pan of the balance with brush. If required, Teepol
solution 0.1% followed by D.M. water and wipe dry with clean
cloth.
7.3 Level the balance property.
7.4 Keep pallets and stainless steel containers near the
balance.
7.5 In case of electronic balance, switch ON the power
supply.
7.6 In case of electronic balance, press the ON switch on the
digital control and wait till it indicates ZERO. In case of
mechanical balance check ZERO reading.
7.7 Balance set to zero, if any error is observed.
7.8 Place the material on the balance platform / pan by one and
check. Check the weights against requisition slip and batch
production record.
7.9 Material tags are tally with the details on Batch Production
Record. Checks tally the name of material, A.R. No., gross weight,
tare weight and net weight of material.
TITLE: SOP FOR CLEANING AND OPERATION OF MANUAL CAPSULE FILLING
MACHINEPage : 01-02
Deptt.: PRODUCTION
SOP No.: SPD/17Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Cleaning and Operation of
Manual Capsule Filling Machine.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:5.1) CLEANING :5.1.1 Loosen the bolt of the capsule
filling machine.
5.1.2 Dismantle all the supporting plates & lock plates from
the machine and dip in water.
5.1.3 Remove the powder from the machine by the Nylon brush.
Transfer all parts to washing area. First clean with 0.1% Teepol
solution or equivalent soap solution by moping with non woven
cloth.
5.1.4 Wash the machine with raw water.
5.1.5 Rinse with DM water.
5.1.6 Dry the machine.
5.1.7 Send a wash water sample for analysis of previous product
to Q/A, Q/C Department.
TITLE: SOP FOR CLEANING AND OPERATION OF MANUAL CAPSULE FILLING
MACHINEPage : 02-02
Deptt.: PRODUCTION
SOP No.: SPD/17Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
5.2) OPERATION:-5.1.1 After receiving the QC report fix a label.
Ready For Use.
5.1.2 After getting QC report, reassemble the capsule machine
for filling of next batch (Product).
5.1.3 Fix the Guide Plate on the machine.
5.1.4 Weigh qty. of powder to be filled for 300 capsules. Put
the powder on the capsule magazine, spray the powder by a plastic
made spreader.
5.1.5 Press the top plate on filled magazine.
5.1.6 Load the caps part of the capsules, and lock the plate by
pressing with handle.
5.1.7 Loosen the lock bolt, remove the filled capsules.
5.1.8 Continue the same process, till the batch is finished.
5.1.9 Record the machine cleaning / operation in record.
Format.
TITLE: SOP FOR CLEANING AND OPERATION OF BLISTER PACKING
MACHINEPage : 01-02
Deptt.: PRODUCTION
SOP No.: SPD/18Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Cleaning and Operation of
Blister Packing Machine.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:Cleaning5.1 Switch OFF the mains.5.2 Clean the blister
packing machine with Teepol solution (0.1%) or eq. soap solution by
nylon cloth / foam.5.3 Remove the blister forming roller, ink
device, hopper, chute, channel, plate ,sealing roller etc.5.4 Clean
them with Teepol solution (0.1%) or eq. soap solution by nylon
cloth / foam.5.5 Rinse with raw water, and finally with DM
Water.5.6 Clean the conveyor belt with the Teepol solution (0.1%)
or eq. soap solution by nylon cloth / foam.5.7 Rinse with raw
water, and then rinse with DM Water.5.8 Close the valve of
compressed air, raw water supply line.5.9 Proper oiling and
greasing in the machine are necessary before installation of
machine.5.10 After drying, reassemble the machine.TITLE: SOP FOR
CLEANING AND OPERATION OF BLISTER PACKING MACHINEPage : 02-02
Deptt.: PRODUCTION
SOP No.: SPD/18Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
6. OPERATION :6.1 Before the starting of the machine check the
sealing roller, forming rolls, guide track, chute, hopper etc.6.2
Open the valve of compressed air and raw water.6.3 Fill the ink pot
with the ink, and fix the stores.6.4 Start the temperature heating
element and roller forming switch.6.5 When temperature reaches at
approx. 160OC, fix the blister/ PVC roll and printed aluminum foil
of the required product.6.6 Now start the machine to check the
forming cavity and sealing of blister strip.6.7 Load the hopper
with tablets/ capsules for commercial packing.6.8 Check the sealing
by Leak Test method.
TITLE: SOP FOR CLEANING AND OPERATION OF DOUBLE CONE BLENDERPage
: 01-02
Deptt.: PRODUCTION
SOP No.: SPD/19Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Cleaning and Operation of
Double Cone Blender.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:CLEANING: 5.1 Switch OFF the mains of Cone Blender.
5.2 Loosen the bolt/ clamp of the cone blender.5.3 Remove the
gasket and top of the mouth from the cone blender, dip in a soap or
Teepol solution (0.05%).
5.4 Clean the cone blender with 0.1% Teepol solution by moping
with non woven cloth.
5.5 Rinse with raw water, finally clean with DM Water.
5.6 Mop the external parts of the cone blender/ frames by the
non woven cloth.
5.7 After complete cleaning of cone blender send wash water
sample for analysis.TITLE: SOP FOR CLEANING AND OPERATION OF DOUBLE
CONE BLENDERPage : 02-02
Deptt.: PRODUCTION
SOP No.: SPD/19Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
6. OPERATION:-6.1 After getting the wash water report, fix a
label MACHINE IS READY FOR USE.6.2 Switch ON the mains.6.3 Add the
batch (Powder) for mixing.6.4 Close the top lid, fitted with
gasket.6.5 Tight the bolts/ clamps.6.6 Start the machine for
mixingCAUTION: Before starting of the machine, keep distance at
least 3 ft. from the machine to
avoid the accident.
TITLE: SOP FOR CLEANING AND OPERATION OF DRY FILLING MACHINEPage
: 01-02
Deptt.: PRODUCTION
SOP No.: SPD/20Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Cleaning and Operation of
Dry Filling Macnine.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:5.1) CLEANING:-5.1.1 Switch OFF the mains.
5.1.2 Loosen the bolt, remove the lock of hopper of dry syrup
filing machine.
5.1.3 Dismantle the auger & nozzle.
5.1.4 Loose the weight variation adjustment lock.
5.1.5 Dip all the dismantled parts in 0.1% Teepol solution.
5.1.6 Mop the dismantled parts by non woven cloth.
5.1.7 Rinse with raw water till frothing is removed.
5.1.8 Clean the external machine parts and body with DM Water by
wet moping and dry the machine.
5.1.9 Finally rinse with DM Water and send a sample of wash
water to the Q.A. department.TITLE: SOP FOR CLEANING AND OPERATION
OF DRY FILLING MACHINEPage : 02-02
Deptt.: PRODUCTION
SOP No.: SPD/20Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
5.2) OPERATION
5.2.1 After getting the result form Q.A. department fix a label
MACHINE IS READY FOR USE.
5.2.2 Reassemble all the dismantled parts of the machine i.e.
auger, weight wheel, hopper etc.
5.2.3 Add the powder/ granules of next batch; switch ON the
mains.
5.2.4 Start the machine and check the weight of fixed quantity
of each bottle.
5.2.5 Check the adjusted weight for at least 10 bottles of dry
syrup.
5.2.6 Now start the production till the batch is finished.
5.2.7 Checking of weight variation of filled dry syrup bottles
is done after every 30 minutes.
5.2.8 Record pertaining to cleaning, operation and weight
variation is recorded in format.
TITLE: SOP FOR CLEANING AND OPERATION OF ROPP CAP BOTTLE SEALING
MACHINEPage : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/21Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Cleaning and Operation of
R.O.P.P. Cap Bottle Sealing Machine.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:5.1 CLEANING:-5.1.1 Switch OFF the mains.
5.1.2 Clean he machine with Teepol solution (0.1%) or eq. soap
solution.
5.1.3 Dismantle the sealing die. Clean with the dry cloth dipped
in diesel to avoid the rust from environment.
5.1.4 Clean the footrest with dry cloth by moping.
5.1.5 Apply the grease / Lubricant oil to the axle of the
footrest and lever of sealing die guide.
5.1.6 Reassemble the die. Finally clean the machine with dry
cloth.
5.2 OPERATION:-5.2.1 Adjust the height of bottle with ROPP cap
dry inching method.
5.2.2 Check the sealing of 10 dry syrup bottles for good quality
of sealing.
5.2.3 Adjust the guide of the bottle pressing plate / lifting
plate with sealing die.
5.2.4 Now start the production till the batch is finished.
5.2.5 Record the total cleaning and operation in record book
format.
TITLE: SOP FOR DECARTONING OF CONTAINERS AND CLOSURESPage :
01-01
Deptt.: PRODUCTION
SOP No.: SPD/22Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Decartoning of Containers
and Clousres.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:5.1 General Rules :
5.1.1 All filling materials must be requested from the warehouse
well in advance. These are supplied in their shipping boxes or
shrink wrapped trays. No shipping box is slowed in clean area.
5.1.2 All excess material supplied which is not used is returned
to warehouse. No unnecessary material is allowed to accumulate in
clean area.
5.1.3 Tearing off paper in the clean area is not permitted.
5.1.4 All wastage is deposited in the dustbins provided.
TITLE: SOP FOR CONTROLLING MICROBIAL CONTAMINATION (Ointment
section)Page : 01-01Deptt.: PRODUCTION
SOP No.: SPD/23Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Controlling Microbial
Contamination (Ointment Section).
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:Controlling Microbial Contamination:- Producing product
of 100% efficacy by adopting following procedures:a)Compounding
room cleans up: - Moping the floor and working table with hot 0.1%
Teepol solution
Rinse the floor and working table with hot water.
Keep personnel traffic to a minimum.
b)Compounding equipment cleans up:- It is done just after
completion of current batch
Clean the melting and compounding vessel with hot 0.1% Teepol
solution.
Scrub the vessel, cover, agitator, scrapper with nylon scrubber
to remover trace of the pervious product. Disassemble the other
equipment which comes in to content with product and clean with hot
0.1% Teepol solution and rinse with DM water and sanitize with 70%
IPA.
If manufacturing equipment is stored for more than three days it
must be resanitize before Use.
c)Filling equipment clean up and sanitization:- Dissemble all
parts that come in contact with product.
Scrub all contact parts with 0.1% hot Teepol solution
Now finally rinse with DM waterTITLE: SOP FOR LINE CLEARANCE
(PACKING)Page : 01-01Deptt.: PRODUCTION
SOP No.: SPD/24Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Line Clearance
(Packing).
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:5.1 Packing line is cleared after every product
changeover.
5.2 All unpacked goods are packed in one container and properly
labeled. It is send to quarantine for storage till next packing
schedule.
5.3 All rejected goods, if recoverable, are properly labeled and
send to recovery quarantine.
5.4 All intact packing materials, boxes, shipper carton, labels
are properly counted and tied and returned to packing store.
5.5 All torn / rejected packing material and rejected goods are
shifted to scrap yard in a polythene bag for disposal.
5.6 The finished goods are accounted for and transferred to
Finished Goods stores along with finished good transfer slip.
5.7 The packing belt / tables are cleaned both from top and
floor and waste is collected in dust bin.
5.8 The packing area/ belt/ table are cleaned and mopped before
starting packing of next product / batch.
5.9 Production Manager / Q.A. Manager jointly conduct line
clearance operation.
5.10 Line clearance operation is recorded in prescribed format
and duly signed by Q.A. Manager/ Production Manager.TITLE: SOP FOR
VISUAL INSPECTIONPage : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/25Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Visual Inspection.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:5.1 Test and release filled bottle of the product
received from quarantine area to visual inspection area.
5.2 Depute the visual inspection team for proper checking of
fiber / glass / black white particles and any foreign matter.
5.3 Check the proper sealing of bottle.
5.4 The complete visual inspection team is divided into 2 group
of expert team.
5.5 Visual inspection is done by unaided naked eye.
5.6 The percentage of rejection found is to be recorded in flow
sheet and register.
5.7 The visual inspection team personnel are needed maintained
accordingly to ensure the proper checking of foreign matter.
5.8 Rotation gap between one group to other group is two
hourly.5.9 Finally calculate the percentage of rejection of
complete batch and transfer to packing department with details
bearing product name, B. No. Size, D/M, D/E.
TITLE: SOP FOR BATCH CODINGPage : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/26Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Cleaning and Operation of
R.O.P.P. Cap Bottle Sealing Machine.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:All the dosage forms are properly categorized with
different codes explaining the details of each individual batch
which is prepared and approved by the authorized personnel
only.A.Name of the authorized personnel
B.Details of the dosage forms for which batch coding
requires.
B1Capsules/ Tablets
B2Dry Syrup
B3Topical Creams and Ointment.
C.Procedure of batch coding.
D1Batch Code have minimum 3-4 digits.
D21st and 2nd place are denote product code as per attached list
e.g.
D33rd and 4th place are denote serial No. of batch e.g. 02
denotes 2nd
batch of the year of that particular product.TITLE: SOP FOR
REPROCESSING OF RECOVERYPage : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/27Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
6) PURPOSE:To lay down a Procedure for Reprocessing of
Recovery.
7) RESPONSIBILITY:Q/C Manager.
8) ACCOUNTABILITY:Production Manager/Q.A. Manager
9) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.10)
PROCEDURE:5.1 The recoverable bottle of the different batches are
collected and reported in new flow sheet with a batch no., batch
size and expiry date must be mentioned of the first batch of
recovery.
5.2 The bottle are collected and transferred in a clean area and
reopened and solution is collected in a S.S. closed container.
5.3 Nitrogen flushing of the recovered solution is done till the
batch is filled.
5.4 Recovered bulk solution is sent for testing to check the pH,
assay and other tests as required.
5.5 After getting the approval from the Q.A. Department
recovered solution is filtered through sterile membrane filter in a
sterile filling vessel.
5.6 Filtered solution is filled as a new batch and new Batch No.
M/D, E/D, is mentioned in each and every stage.
5.7 The expiry of the new batch is the expiry of the oldest
recorded batch.
5.8 Recovery details are to be recorded in the presented format
of the Batch Record.
TITLE: SOP FOR LEAK TEST FOR CAPSULES/TABLETS (STRIP AND BLISTER
PACKING)Page : 01-02
Deptt.: PRODUCTION
SOP No.: SPD/28Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Leak Test for Capsules /
Tablets (Strip and Blister Packing).
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:5.1 A sample of 4 strips (pr equivalent to 40 pockets,
whichever is higher) to be collected from the machine at the time
of start up and then at an interval of 1 hours.
5.2 Place the sample into a vacuum dessicator containing enough
water to cover the sample with at least one inch of water (measured
from the top surface of package). Use a metal grid or screen to
hold the sample submerged.
5.3 Close the dessicator and slowly apply 10 inches (25 cm) of
vacuum as read on a vacuum gauge, taking between 30 seconds and one
minute to raise the vacuum. Hold under vacuum for 3 minutes.
Present the vacuum line for 10 inches of vacuum by means of
valve.
5.4 Slowly release the vacuum and remove the samples.
5.5 Carefully dry the samples with tissue paper or soft
cloth.TITLE: SOP FOR LEAK TEST FOR CAPSULES/TABLETS (STRIP AND
BLISTER PACKING)Page : 02-02
Deptt.: PRODUCTION
SOP No.: SPD/28Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
5.6 Examine all pockets for evidence of leakage, i.e. water.
5.7 If one pocket shows evidence of leakage, reject the sample,
stop the line, and immediately notify the packing line supervisor
so that corrective action may be taken.5.8 After adjustment of the
sealing machine, select another representative set of samples, and
repeat the leak test. If no leakage is detected, the line may be
restarted. If leakage of any sample is still evident, adjust the
machine and perform re-testing until the process is demonstrated to
be under control.
5.9 Record the results of all tests in the packing record,
indicating the time tested, the sample size, the number of leaking
samples, found, the corrective action taken and the result of
further testing.
TITLE: SOP FOR CLEANING & OPERATION OF CAPSULE LOADER
MACHINEPage : 01-03
Deptt.: PRODUCTION
SOP No.: SPD/29Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Cleaning and Operation of
Capsule Loader Machine.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE: FOR PRODUCT TO PRODUCT CHANGEOVER:1.Dedusting external
surfaces:-
Use clean nylon brush and wipe with clean dry lint free
duster.
2.Dismantling Remove:-
(a)Back and front cover.
(b)Empty capsule hopper.
(c)Magazine followed by pusher plate and raceway.
3.Cleaning of parts:-
Clean the above parts by washing with 0.1% Teepol solution and
scrubbing with soft nylon brush. Rinse with jet of potable water
followed by rinsing with D.M. water. Clean loading platform with
wet duster. Clean back and front cover and empty capsules hopper
using clean dry lint free duster.TITLE: SOP FOR CLEANING &
OPERATION OF CAPSULE LOADER MACHINEPage : 02-03
Deptt.: PRODUCTION
SOP No.: SPD/29Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
4.Drying:-
The cleaned parts as mentioned in step 3 are wiped and dried
using clean dry lint free duster.
5.Assembling:-
Reassemble all the parts of the machine carefully checking the
correctness of assembling.
Note:5.1 Fix the cleaned label.
5.2 If the cleaned loader is not used within 24 hours after
cleaning or there are sign of dust or powder settled on loader,
then wipe the body by using a freshly laundered lint free
duster.
6. PROCEDURE FOR BATCH TO BATCH CHANGEOVER:-6.1 Empty out the
hopper.
6.2 Remove back and front cover.
6.3 Remove empty capsules from loading platform by bursh.
6.4 Dry-clean the loader with clean dry lint free duster.
CAUTION: In case of any abnormal sound from machine during its
operation, stop the machine and report to maintenance.TITLE: SOP
FOR CLEANING & OPERATION OF CAPSULE LOADER MACHINEPage :
03-03
Deptt.: PRODUCTION
SOP No.: SPD/29Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
7. ASSEMBLING:-7.1Assemble clean and dry accessories in
following manner.
7.2 Raceway along with pusher slide and magazine
7.3 Front and back cover.
7.4 Empty capsules hopper.
8. OPERATION:-8.1 Ensure that all parts of machine are cleaned
as per standard procedure.
8.2 Load empty capsules in hopper.
8.3 Switch on mains of machine.
8.4 Fit capsules loading plate on loading table.
8.5 Push loading plate inside by turning front knob in clockwise
direction. Push the green button to load capsules.
9. DISMANTLING:-9.1 Remove the front and back cover.
9.2 Remove the empty capsules hopper.
9.3 Remove magazine followed by pusher plate and raceway. Clean
machine and dismantled parts as per standard cleaning
procedure.
10. CAUTIONS: Switch off the electrical mains of the
machine.
TITLE: SOP FOR CLEANING & OPERATION OF DEHUMIDIFIERPage :
01-02
Deptt.: PRODUCTION
SOP No.: SPD/30Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Cleaning and Operation of
Dehumidifier.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:5.1) Switch off the mains
5.2) Clean all surfaces of instruments by clean dry cloth, then
with wet cloth dipped in 0.1% Teepol solution.
5.3) Clean it again with next dry lint free cloth.
5.4) Take out the Pre-filter and wash it with 0.01% Teepol
solution and finally with DM Water.
5.5) Dry pre-filter with the dry heat blow.
5.6) The water storage SS tank is thoroughly washed and cleaned
with 0.1% Teepol solution and finally with DM Water.5.7) 1st ice
formation takes place on the inner surface of Pre-filter. Get it
cleaned by spraying hot DM Water spray and finally get it dried by
blowing warm air current.
TITLE: SOP FOR CLEANING & OPERATION OF DEHUMIDIFIERPage :
02-02
Deptt.: PRODUCTION
SOP No.: SPD/30Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
6. OPERATION:-6.1 Ensure that all parts of machine are cleaned
as per standard procedure.
6.2 Check the manufacturing area from the point of exposures and
disturbances.
6.3 Switch on mains of electricity supply after all setting of
its implements, if area is found perfect.
6.4 Keep it ON before one and half hours of the start of
working.
6.5 Check relative humidity percent of the area half on
hourly.
6.6 After getting the desired temperature and relative humidity
percentage, production conducted scientifically.
6.7 Temperature regulation of the working area is to be
controlled by air conditioning procedure.
6.8 Record all valuable data in record format.
CAUTION: In case of any abnormal sound or disturbance from
machine during operation, stop it and report to maintenance for
overhauling.
TITLE: SOP FOR CLEANING & OPERATION OF STRIP PACKING
MACHINEPage : 01-02
Deptt.: PRODUCTION
SOP No.: SPD/31Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Cleaning and Operation of
Strip Packing Machine.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:5.1 CLEANING:5.1.1 Switch OFF the mains.
5.1.2 Clean the strip-packing machine with Teepol solution
(0.1%) or eq. soap solution by nylon cloth / foam.
5.1.3 Remove the strip forming roller, ink device, hopper,
chute, channel, plate, sealing roller etc.
5.1.4 Clean them with Teepol solution (0.1%) or eq. soap
solution by nylon brush/ brass brush.
5.1.5 Rinse with raw water, and finally with DM Water.
5.1.6 Clean the conveyor belt with the Teepol solution (0.5%) or
eq. soap solution by nylon cloth / foam.
5.1.7 Rinse with raw water. Then Rinse with DM Water.
5.1.8 Proper oiling and greasing in the machine is necessary
before installation of machine.
5.1.9 After drying, reassemble the machine.TITLE: SOP FOR
CLEANING & OPERATION OF STRIP PACKING MACHINEPage : 02-02
Deptt.: PRODUCTION
SOP No.: 31Effective Date: 15-07-2007Revision No.:Review Date:
14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign......Sign...
5.2 OPERATION :
5.2.1 Switch OFF the mains.
5.2.2 Before the starting of the machine, check the sealing
roller, forming rolls, guide track, chute, hopper etc.
5.2.3 Fill ink with the inkpot, and fix the stereos.
5.2.4 Start the temperature-heating element and forming roller
switch.
5.2.5 When temperature reaches at approx 120OC. fix the aluminum
foil of the required product.
5.2.6 Now start the machine to check the forming cavity and
sealing of strip.
5.2.7 Load the hopper with capsules/ tablets for commercial
packing.
5.2.8 Check the sealing of strip by leak test method.
TITLE: SOP FOR CLEANING & OPERATION OF SIFTERPage :
01-02
Deptt.: PRODUCTION
SOP No.: SPD/32Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Cleaning and Operation of
Sifter.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:As soon as the shifting process is over, dismantle the
following parts:a)SS feed hopper
b)SS frame, holding the sieve in place
c)SS wire mesh sieve.
5.1 Remove all the residual powder adhering to the above
mentioned articles with the help of a nylon brush.5.2 Wash these
articles with hot water.5.3 Wash these articles with 0.1% Teepol
solution.5.4 Clean these articles with running water to remove all
traces of detergent.5.5 Drain off all the water and dry all the
articles.5.6 Clean the exterior of the sifter stand and motor
assembly with the help of a lint free wet cloth.5.7 Carry out step
1 to 5 for the SS base plate with discharge outlet attached to the
sifter stand.5.8 Assemble all the cleaned / dried articles from
step 5 on the Sifter stand frame.TITLE: SOP FOR CLEANING &
OPERATION OF SIFTERPage : 02-02
Deptt.: PRODUCTION
SOP No.: SPD/32Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
6. Affix a clean label giving following information:
a) Name of the equipment.
b) Name of the last product shifted.
c) Name of the operator who cleaned the equipment.
d) Date of cleaning.
e) Supervised by
7. OPERATION:
7.1 Before starting the shifting operation, ensure that the
machine is clean.7.2 Put appropriate quantity of material to be
shifted on the SS mesh sieve using cleaned SS scoops.7.3 Tie
polybags kept in SPD/Plastic drums to the outlet of Sifters with
the help of twine.7.4 Switch ON the machine.7.5 After the drum is
filled to 80-90% capacity, tie the polybag, close the lid of drum
and fix identification label on it showing the Name, Batch No.
& Batch Size of the product.7.6 Repeat steps 2 to 5 until the
shifting process is completed.7.7 After the operation is over, fix
To be cleaned label on the machine.7.8 Clean the Sifter as per
SOP.
CAUTION: Please clean before use.
TITLE: SOP FOR HANDLING OF FINISHED PRODUCTS IN STOREPage :
01-03
Deptt.: PRODUCTION
SOP No.: SPD/33Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Handling of Finished
Products in Store.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:5.1 Goods laying in the factory goods distribution
store.
5.2 If the product has remained in the above stores for a longer
period then on the request of store In-Charge, the goods are
sampled and subjected to stringent inspection and required analysis
by Q.C. Department.
5.3 Random sampling is carried out by the in process supervisor
in presence of Q.C. officer in accordance with the statistical
Production & for this purpose normal level of sampling to be
done.
5.4 Samples collected from the stores and sent to the Q.C.
Department for analysis Within 15 days along with format test
reports are reported. The operation on the suitability or otherwise
of product for distribution is also forwarded along with analysis
report by Q.C. Manager to the store In-charge.
5.5 If the product is found satisfactory by Q.C. department it
can be released for distribution.
5.6 If the results are unsatisfactory the product returned by
the stores in charge to the factory for reprocessing and repacking
if required, immediately after the receipt of the Q.C. report.
5.7 If the quality of the product during storage is found to
have deteriorated / degraded to an extent that it is unfit for
re-processing the same is destroyed with the permission of
production director/ production manger in presence of
representative of Q.C. department certificate to this effect in
triplicate and Signed by the store in charge and Q.C. manager
issued, one copy to be retained by the Signing authorities and
third copy to be filled in the BPR, of concerned batch of the
product.TITLE: SOP FOR HANDLING OF FINISHED PRODUCTS IN STOREPage :
02-03
Deptt.: PRODUCTION
SOP No.: SPD/33Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
5.8 The following particulars are entered in the register
maintained by stores:-5.8.1 Serial No.
5.8.2 Name of the product.
5.8.3 Date of Mfg. and Date of Exp.
5.8.4 Quantity involved.
5.8.5 Randomly sampled Quantity
5.8.6 Stock in hand.
5.9 The following particulars are entered in the register
maintained by Q.C.
Department:-5.9.1 Serial No.
5.9.2 Name of the product.
5.9.3 Date of Mfg. & Date of Exp.
5.9.4 Sample received from
5.9.5 Date of receipt
5.9.6 Date of analytical report
5.9.7 QA Managers opinion
5.9.8 Quantity destroyed.
5.9.9 Date of destruction of stocks.
5.9.10 Signature of Q.C. Manager.
5.10 Goods lying in branch ware /house company depots if any
:-5.11 Products may be damaged during transport. It can be in the
form of breakages without damage to content or physical damage.
Base on the type and extent of damage. Branch or depot in-charge is
decide the action. The inchange samples the product as per sampling
plan and send for Q.C. Department.TITLE: SOP FOR HANDLING OF
FINISHED PRODUCTS IN STOREPage : 03-03
Deptt.: PRODUCTION
SOP No.: SPD/33Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
5.12 Goods lying in the transporters go-down or received back by
the depot from market.
5.13 The product inspected for physical damage, if any on
receipt from the transporters go-down by the stores in-charge at
the branch depot, based on the type and extent of damage. The
branch personnel are further action.
5.14 If the product needs any re-dressing or reprocessing the
same is subjected to treatment as above.
TITLE: SOP FOR PACKING OPERATIONPage : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/34Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Packing Operation.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:5.1 After issue of packing material from warehouse, check
for identity and quantity.
5.2 Store printed material properly
5.3 Before starting of operation the labels and cartons are
checked for any defect.
Check identity of product & Quantity of product before
starting of packing operation.
5.4 Before starting fresh batch all material required are
brought and kept at relevant place only.
5.5 Get the line clearance.
5.6 After packing is over, inform Q.A. for their check.
5.7 Deliver the goods to the warehouse only on receipt of final
approval from Q.A.
5.8 Disposal of excess labels, cartons and records is done as
per SOP No. SPD/12.
5.9 Clean up the area at the end of days work.
TITLE: SOP FOR CLEANING OF PASTE KETTLEPage : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/35Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Cleaning of Paste
Kettle.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:5.1 The General Utensils like S.S. Container, S.S.
Scoops, and S.S. Trays etc. are washed with water.
5.2 Wash with liquid soap or detergent with gentle rubbing. Then
wash with fresh water until the detergent foam is completely washed
out.
5.3 Finally wash with DM water and get wash utensils checked
from the Q.C. lab.
5.4 Mop with dry, clean cloth.
TITLE: SOP FOR GENERAL CLEANING OF EQUIPMENT IN MANUFACTURING
AREAPage : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/36Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for General Cleaning of
Equipment in Manufacturing Area.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:5.1 Check electrical terminals for insulation and
soundness of terminal connections. Check soundness of electrical
switches and its contacts.
5.2 At the end of the shift the equipment is cleaned.
5.3 Clean all the machine parts using potable water. Then wash
with 0.1% Teepol solution. Then rinse with potable water and then
rinse with D.M. Water.
5.4 Finally rinse with D.M. water and send the wash water to
Q.C. Department for analysis.
5.5 Wipe dry the surfaces, using clean dry cloth.
5.6 After getting O.K. report from Q.C. Department, put a tag on
machine CLEAN & READY FOR USE.
TITLE: SOP FOR ADVERSE HEALTH CONDITION OF PERSON IN
MANUFACTUEING AREAPage : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/37Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Adverse Health Condition
of Person in Manufacturing Area.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:5.1 The people who are sick & ill or suffering from
any disease are not permitted in production area.
5.2 The production Deptt. allows sick leave to sick person.
5.3 If any person feels discomfort in the production area or
feel ill then inform immediately to concern supervisors /
in-charge.
5.4 As a fixed policy of organization, the people are shifted
outside the production area under medical aid.
TITLE: SOP FOR INTERNAL LABELING DURING QUARANTINE, STORAGE AND
PROCESSINGPage : 01-02
Deptt.: PRODUCTION
SOP No.: SPD/38Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Internal Labeling during
Quarantine, Storage and Processing.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:5.1 Paste Material under Test printed yellow sticker on
all the containers, of that material, which are under test.
5.2 Paste Approved slip printed green sticker on the entire
container, of those material which are Tested by Q.C. Deptt.5.3
Paste Sampled printed sticker on those containers, whose content
are sampled.
5.4 Paste Rejected printed red sticker on those containers,
which contain rejected material.
5.5 Paste the following sticker on containers which are under
operation.TITLE: SOP FOR INTERNAL LABELING DURING QUARANTINE,
STORAGE AND PRICESSINGPage : 02-02
Deptt.: PRODUCTION
SOP No.: SPD/38Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
Sticker3.3 IDENTIFICATION SLIP
1.Name of Product ..
2.Batch No.
3.Batch Size
4.Mfg. Date..
5.Exp. Date
6.Remarks
Signature
TITLE: SOP FOR RECEIPT OF PACKING MATERIAL IN PRODUCTIONPage :
01-01
Deptt.: PRODUCTION
SOP No.: SPD/39Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Receipt of Packing
Material in Production.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE:5.1 Prepare requisition slip for the packing
material.
5.2 Check and certify that the requisition slip is correct in
all respect and get it authorized from production manager.
5.3 Deposit in stores for issuing the packing material.
5.4 Receive the issued material through the packing store
material gate of production block.
5.5 Physically check and count all packing material received
against requisition slip.
5.6 Acknowledge the receipt of material on requisition slip and
file the departmental copy of BPR.
5.7 Stock the issue quantities properly in a manner to avoid
damage due to over loading or fall down.
5.8 Store the received labels in cupboard and other printed
packing components in a locked room. Restrict the access to this
area.
5.9 Segregate the similar looking packing components.
5.10 Store the adhesives in tight container.
TITLE: SOP FOR DISPOSAL & SALAVAGE OF REJECTED/ EXPIRED/
UNUSABLE MATERIALSPage : 01-03
Deptt.: PRODUCTION
SOP No.: SPD/40Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
1) PURPOSE:To lay down a Procedure for Disposal and Salavage of
Rejected / Expired / Unusable Material.
2) RESPONSIBILITY:Q/C Manager.
3) ACCOUNTABILITY:Production Manager/Q.A. Manager
4) SCOPE:The procedure of this SOP shall be applicable to
Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5)
PROCEDURE: The procedure mentioned has deals with three categories
of unusable materials:-5.1)Rejected Material:a)Which does not
confirm the stipulated standard?b)Rejection during processing to
store.
c)Final product which fails to meet the standard.5.2) Expired
Materials: Input materials or finished product which has lost
its
credential due to non-usage for a period of over the years.5.3)
Unusable Materials:a)Information of such items, which have become
obsolete due to change of process / packing materials, which have
lost its physical / chemical or biochemical properties.b)All
rejected, expired and unusable materials are pasted with red
stickers, so that they can be identified and are physically
separated from the other materials.c)These materials are kept
either in its original packing or in double poly bags duly knitted
or sealed and bearing a sticker (red) with following
informations.TITLE: SOP FOR DISPOSAL & SALAVAGE OF REJECTED/
EXPIRED/ UNUSABLE MATERIALSPage : 02-03
Deptt.: PRODUCTION
SOP No.: SPD/40Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
RED COLOURED STICKER OF REJECTED MATERIALS
SARTHAK BIOTECH Pvt. Ltd.,
198/A, Sector-3, HSIIDC, KARNAL-132 001
D.L. No. : 619 B (H) & 977 OSP (H)
REJECTED
Pack No.______________
Raw Material___________________________________Batch
No.______________________________________Date of
Mfg.____________________________________Date of
Exp.____________________________________Qty.___________________________________________Mfg.
By________________________________________
Supplied By_____________________________________Test
Date_______________________________________Analytical Report
No._____________________________Control Ref.
No__________________________________Failed
Parameter_________________________________ Sig. of Q.C. Person
These materials are kept in a separate area in stores and
periodically disposed off by either returning them to the supplier
or sending them to scrap yard. From scrap yard the saleable items
are sold through scrap dealers.
Other materials are destroyed by burning. Raw materials,
Chemicals, powders are drained out after proper treatment.
The record of disposal is maintained at production/ stores
department, in the form of registers.
TITLE: SOP FOR DISPOSAL & SALAVAGE OF REJECTED/ EXPIRED/
UNUSABLE MATERIALSPage : 03-03
Deptt.: PRODUCTION
SOP No.: SPD/40Effective Date: 15-07-2007Revision No.:Review
Date: 14-07-2009
Prepared by:
Asstt. Production ChemistChecked By:
Production ManagerApproved By
Q.A. ManagerDirector
Sign..Sign..Sign....Sign...
All the salvage by burning is authentic carSed by the following
person.
1) In charge of either Production / Stores (concurred
deptt.)
2) In-charge of Production.
The record of such