SASBIOSYNTH 1 General Information DESCRIPTIONS SAS BIOSYNTH PVT LTD WHO-GMP CERTIFIED COMPANY located at BADDI- Himachal Pradesh (India) its corporate office at Rajarhat Road ,New Town , Kolkata . The company was established in 2005 by Mr.Soumen Dey , a qualified Pharmacist having a decade of experience in marketing and manufacturing of Pharmaceuticals. Manufacturing unit no.1. is situated at Nalagarh Baddi Highway, BADDI, Distt. Solan, Himachal Pradesh (India), no2. is at KALA AMB ,HIMACHAL PRADESH . Manufacturing facility includes dedicated Beta-Lactam & Non Beta-Lactam & Other Pharmaceutical production units. The manufacturing facility has state of the art manufacturing infrastructure (Tunnel Systems) for the production of Pharmaceutical dosage forms. In-house Quality Control Laboratories having state of the art equipments for testing the quality of pharmaceutical products at each stage of manufacturing. The Utility includes Heating Ventilation Air Conditioning System, Water Purification Systems, Water for Injection System, Steam Generation System, Filtered Nitrogen System, Filtered Compressed Air System, Boiler & Diesel Generators to support the manufacturing activities. The company has a team of highly qualified & experienced professionals who supervise, control and monitor the process & quality of its Pharmaceutical products at each stage of manufacturing. Manufacturing Facility is ISO 9001-2000 and WHO-GMP certified. SAS BIOSYNTH is licensed to manufacture, store and distribute for sale of Biological & Non Biological Pharmaceutical preparations ,licensed by State Drug Licensing Authority- Himachal Pradesh (India). Pharmaceutical Formulations covering different dosage forms are: 1) Injection (dry and liquid forms) including pre filled syringes 2) Eye/Ear Drops 3) Dry syrup 4) Liquid Syrup 5) Sterile & Non Sterile Ointment 6) Capsule 7) Sachets (Dry & Liquid) SAS BIOSYNTH has established its niche by virtue of the quality of its products, & are being marketed all over India & for exports. The factory is located on a total area of 93000 sq ft. The site is located at around 1 kilometer from Baddi towards the national highway.
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SASBIOSYNTH 1
General Information DESCRIPTIONS
SAS BIOSYNTH PVT LTD WHO-GMP CERTIFIED COMPANY located at BADDI-Himachal Pradesh (India) its corporate office at Rajarhat Road ,New Town , Kolkata . The company was established in 2005 by Mr.Soumen Dey , a qualified Pharmacist having a decade of experience in marketing and manufacturing of Pharmaceuticals. Manufacturing unit no.1. is situated at Nalagarh Baddi Highway, BADDI, Distt. Solan, Himachal Pradesh (India), no2. is at KALA AMB ,HIMACHAL PRADESH . Manufacturing facility includes dedicated Beta-Lactam & Non Beta-Lactam & Other Pharmaceutical production units. The manufacturing facility has state of the art manufacturing infrastructure (Tunnel Systems) for the production of Pharmaceutical dosage forms. In-house Quality Control Laboratories having state of the art equipments for testing the quality of pharmaceutical products at each stage of manufacturing. The Utility includes Heating Ventilation Air Conditioning System, Water Purification Systems, Water for Injection System, Steam Generation System, Filtered Nitrogen System, Filtered Compressed Air System, Boiler & Diesel Generators to support the manufacturing activities. The company has a team of highly qualified & experienced professionals who supervise, control and monitor the process & quality of its Pharmaceutical products at each stage of manufacturing.
Manufacturing Facility is ISO 9001-2000 and WHO-GMP certified.
SAS BIOSYNTH is licensed to manufacture, store and distribute for sale of Biological &
Non Biological Pharmaceutical preparations ,licensed by State Drug Licensing Authority-Himachal Pradesh (India).
Pharmaceutical Formulations covering different dosage forms are: 1) Injection (dry and liquid forms) including pre filled syringes 2) Eye/Ear Drops 3) Dry syrup 4) Liquid Syrup 5) Sterile & Non Sterile Ointment 6) Capsule 7) Sachets (Dry & Liquid) SAS BIOSYNTH has established its niche by virtue of the quality of its products, & are being marketed all over India & for exports. The factory is located on a total area of 93000 sq ft. The site is located at around 1 kilometer from Baddi towards the national highway.
SASBIOSYNTH 2
SAS BIOSYNTH was established in the year 2005. Since inception it’s basic thrust was providing quality pharmaceuticals at cost effective prices with total customer satisfaction. SAS BIOSYNTH’s products are well accepted & established all around the globe through valuable customers with its products registered with various multinational companies are being sent to most of the countries like Nigeria, Ghana, Kenya, Srilanka, Vietnam, Iraq, Jordan, Azerbaijan and some CIS countries to name a few.
TABLES OF CONTENTS
1. GENERAL INFORMATION
1.1 Approval Signature
1.2 Revision Summary
1.3 Brief Information about the Firm
1.4 Any other manufacturing Activities
1.5 Site Address with phone & fax
1.6 Formulations manufacture in the Plant
1.7 Use of outside Technical guidance
1.8 Description of Quality management
2. MANAGEMENT
2.1 Qualification, experience and responsibility of management
3 PERSONNEL
3.1 Organization Chart
3.2 Qualification, Experience and responsibility of Key Personnel
3.3 Training and their records
3.4 Health requirements
3.5 Personal hygiene
4 PREMISES
4.1 Site plan of Manufacturing Area
4.2 Nature of Construction and finishing
4.3 Ventilation Systems with Schematic diagram
4.4 Special area for handling Toxic drugs
4.5 Description of Water with Schematic diagram
4.6 Preventive maintenance program for premises
5. EQUIPMENT
5.1 Brief Information of the equipment used in the production and quality Control
department.
5.2 Description of planned preventive maintenance program and reporting system
SASBIOSYNTH 3
5.3 Qualification and calibration including recording system, system Validation.
6. SANITATION
6.1 Cleaning records of area and equipment
7. DOCUMENTATION
7.1 Arrangements for preparation revision and distribution of necessary
documentation for manufacturing.
7.2 Microbial control of air and water.
8. PRODUCTION
8.1 Brief description of production operation using Flow diagram , specifying the
important step and process parameters
8.2 Arrangements for handling materials like Raw materials and Packing materials
and release of the products.
8.3 Arrangements of handling rejected materials
8.4 General policy of Process Validation
9. QUALITY CONTROL DEPARTMENT
9.1 Description of Quality control Department and their systems
10. CONTRACT MANUFACTURING AND ANALYSIS
11. DISTRIBUTION COMPLANTS AND PRODUCT RECALL
12. SELF INSPECTION
13. STABILITY STUDIES
14. OUR VISION
15. QUALITY OPERATIONS
16. INSTALLED CAPACITY
Prepared By Checked by Approved by
Mr.K.S.Thakur B.K.ARSHAN B.K.RAJPUT
MANAGER AGM ( DGM-QA)
1. GENERAL INFORMATION
1.1 APPROVAL SIGNATURE
PREPARED BY SIGNATURE DATE
SASBIOSYNTH 4
Mr. K.S THAKUR
CHECKED BY SIGNATURE DATE
B. K .ARSHAN
APPROVED BY SIGNATURE DATE
B.K.RAJPUT
1.2 REVISION SUMMARY
Supersedes No. Effective Date Reason for Revision
Nil ………
1.3 BRIEF INFORMATION ABOUT THE FIRM
SASBIOSYNTH is promoted by an experienced vibrant team of Techno Commercial
Professionals with sound financial acumen. The Company has hands on experience in Pharma
trading & manufacturing.
The Directors of “SAS BIOSYNTH “are already in this field for many years.
Mr SOUMEN DEY Managing Director
The state-of-art-manufacturing facility is situated in Excise Free Zone-BADDI Distt. Solan
(Himachal Pradesh) & second plant in KALA AMB, HIMACHAL PRADESH India. Plant is WHO-
SASBIOSYNTH 5
GMP certified by the Drug authority of India. Productions team can satisfy customer
requirements for a wide range of products portfolio, meeting quality expectation & specification.
The electricity load sanctioned from the H.P.S.E.B is near about 1000KW.
All production activities have been drawn out to follow high standards of "Good Manufacturing
Practice" and in accordance with cGMP this state of art plant is geared up with latest fully
automatic production machineries from fame suppliers with high capacity and very high quality
norms.
A standard operating Procedure is being put into place which would be applicable to all
Departments and would be strictly enforced. Quality audits would be performed at regular
intervals by a self inspection team of representatives from quality assurance, production,
maintenance & HRD departments which would ensure that the Standard Operating Procedure is
being followed by all the employees.
“To practice GMP is our motto” is the punch line of “SAS BIOSYNTH”
1.4 ANY OTHER MANUFACTURING ACTIVITIES
No activities other than manufacturing of formulation dosage form are done.
1.5 SITE ADDRESS WITH PHONE & FAX
NAME AND EXACT ADDRESS OF FIRM
Corporate Office & works Office
Contact Person Designation MobileNo. Phone No.
Mr SOUMEN DEY Managing Director 09062331627 91-33-26434941
COLUMN DEGASSING UNIT, MIXED RESIN BED WITH 5 micron FILTERS AND 0.2 micron
FILTERS WITH UV LAMPS.
4.5.1 The production of DM water involves the cleaning for column and regeneration of
the same.
4.5.2 All the columns are cleaned by back flushing, taking care that the packing of
column is not disturbed. Carbon column are sanitized by steam.
4.5.3 DM water flowing out of the system is monitored for its conductivity measured by
the conductivity meter. UV lamp is connected on line to reduce the microbial load. The
DM Plant has a circulatory loop line system to maintain the flow of water. All the
connecting pipes made of SS is being sanitized in regular interval as per the SOP with
steam.
SASBIOSYNTH 29
4.6 PREVENTIVE MAINTENANCE OF THE PREMISES
The house keeping team is given the charge to make the premises clean and tidy. An
experience supervisor takes the lead with his experience and makes sure that the
premises are always clean. The same team takes care of Pest control on regular basis
and keeps the cleaning records as per the procedure mentioned in the SOP. The house
keeping staffs are given training in regular intervals as per the cGMP norms.
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5. EQUIPMENT :
5.1 DETAIL OF MACHINERY USED IN THE UNIT. LIQUID SECTION
Sr No.
Machine/equipment description
1. Automatic Washing, Filling, Sealing,Inspection&Labelling Machine(96bpm Washing, 6 Head Filling &6 Head Sealing &Wet Glue Labelling) Gmp Model
2. Automatic Liquid manufacturing plant of capacity 3000 Lts with 3000 Lts capacity storage tank with homogeniser, bucket filter,filter press,transfer pump etc.
3. Transfer trolly 24”x 30”, GMP model
4. Bottle transfer trolly, GMP model
OINTMENT SECTION STERILE Sr No. Machine/Equipment
Description 1. Ointment Manufacturing Plant 500 Kg Capacity ,
GMP Model 2. Ointment Filling, Sealing & Coding Machine,Model SAU1
GMP Model OINTMENT SECTION NON STERILE
Sr No. Machine/Equipment Description
1. Ointment Manufacturing Plant 1000 Kg Capacity , GMP Model
2. Ointment Filling, Sealing & Coding Machine,Model SAU1 GMP Model
36 DEMINRELISED WATER PLANT CA-150 GF-036 ION EXCHANGE 37 SOFT WATER PLANT SWP-100 GF-037 ION EXCHANGE 38 EFLUENT TREATMENT PLANT ETP-1000 GF-038 WOCK OLIVER 39 BOILER RXA-200 GF-039 THERMAX 40 DEMINRELISED WATER PLANT CA-150 GF-040 ION EXCHANGE 41 SHRINK PACK TUNNEL LHS-115 GF-041 SHRINK ENG 42 SHRINK PACK TUNNEL LHS-115 GF-042 SHRINK ENG 43 BUNG WASHING M/C VARTICAL GF-043 INDO GERMAN 44 LAMMINAR AIR FLOW 3x6 4x4 GF-044 THERMADYNE 45 LAMMINAR AIR FLOW 4x4 3x6 GF-045 THERMADYNE 46 LAMMINAR AIR FLOW 3x10 GF-046 THERMADYNE 47 LAMMINAR AIR FLOW 3x6 GF-047 THERMADYNE 48 LAMMINAR AIR FLOW 4x4 GF-048 THERMADYNE 49 LAMMINAR AIR FLOW 4x4 GF-049 THERMADYNE 50 LAMMINAR AIR FLOW 4x4 GF-050 THERMADYNE 51 LAMMINAR AIR FLOW 4x4 GF-051 THERMADYNE 52 LAMMINAR AIR FLOW 3x10 GF-052 THERMADYNE 53 CONVEAR BELT 15 FIT GF-053 LAXMI ENG. 54 CONVEAR BELT 15 FIT GF-054 LAXMI ENG. 55 CONVEAR BELT 10 FIT GF-055 LAXMI ENG. 56 TURN TABLE 32 INCH GF-056 LAXMI ENG. 57 TURN TABLE 32 INCH GF-057 BHOLE ENG. 58 TURN TABLE 32 INCH GF-058 BHOLE ENG. 59 TURN TABLE 32 INCH GF-059 BHOLE ENG. 60 SHRINK PACK TUNNEL LHS-115 GF-060 SHRINK ENG 61 BOX PACKING M/C FXJ-6050 GF-061 BROTHERS 62 VISUAL INSPECTION TABLE 2 SIDES GF-062 BHOLE ENG.
63 WEIGHING BALANCE (PACKING) EWB-30 GF-063 MODERN EQUIP.
64 WEIGHING BALANCE ( PACKING) EWB-30 GF-064 MODERN EQUIP.
65 ELECTRIC CONTROL PANEL ECP-630 GF-065 SHIVAM IND. 66 LAMMINAR AIR FLOW 4x3, 8x3 GF-066 THERMADYNE 67 LAMMINAR AIR FLOW 4x3, 8x3 GF-067 THERMADYNE 68 FLY KILLER (1) 2 FIT 40W GF-068 PHILIPS 69 FLY KILLER (2) 2 FIT 40W GF-069 PHILIPS 70 FLY KILLER (3) 2 FIT 40W GF-070 PHILIPS 71 FLY KILLER (4) 2 FIT 40W GF-071 PHILIPS 72 FLY KILLER (5) 2 FIT 40W GF-072 PHILIPS
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73 PRESSURE VESSEL PV-100 GF-073 INDO GERMAN 74 PRESSURE VESSEL PV-100 GF-074 INDO GERMAN 75 PRESSURE VESSEL PV-100 GF-075 INDO GERMAN 76 VIAL FILLING MACHINE ( MANUAL) VFM-20 GF-076 LAXMI ENG. 77 TURN TABLE 32 INCH GF-077 LAXMI ENG. 78 TURN TABLE 32 INCH GF-078 LAXMI ENG. 79 TURN TABLE 32 INCH GF-079 LAXMI ENG. 80 TURN TABLE 32 INCH GF-080 LAXMI ENG. 81 PASS BOXES 5 Nos 2x2 GF-081 FOOD PHARMA 82 MEMBRANE HOLDER 16 INCH GF-082 INDO GERMAN 83 DISPENSING STATION GF-083 THERMADYNE 84 TRANSFORMER GF-084 85 C T V T GF-085 86 SS TROLLYE GF-086 87 FIRE EXICUTER (CO2) 1 Nos FE-50 GF-087 NATIONAL FIRE 88 FIRE EXICUTER (CO2) 2 Nos FE-05 GF-088 NATIONAL FIRE 89 FIRE EXICUTER (ABC) 2 Nos EF-05 GF-089 NATIONAL FIRE 90 RACK (STORE) GF-090 91 RACK (STORE) GF-091
92 AIR CARTAIN ( ENTERENCE) 3 FIT GF-092 VITZUA CARTAINS
93 AIR CARTAIN ( ENTERENCE) 4 FIT GF-093 VITZUA CARTAINS
94 AIR CARTAIN ( ENTERENCE) 3 FIT GF-094 VITZUA CARTAINS
95 AIR CARTAIN ( RECEPTION) 5 FIT GF-095 VITZUA CARTAINS
FIRST FLOOR
S.No. NAME OF MACHINE MODEL NO. CODE NO. MFD. BY
1 AIR HANDLING UNIT AHU-5000 FF-001 WAVES 2 AIR HANDLING UNIT AHU-1200 FF-002 WAVES 3 AIR HANDLING UNIT AHU-3650 FF-003 WAVES 4 AIR HANDLING UNIT AHU-1100 FF-004 WAVES 5 AIR HANDLING UNIT AHU-750 FF-005 WAVES 6 AIR HANDLING UNIT AHU-2655 FF-006 WAVES 7 AIR HANDLING UNIT AHU-1850 FF-007 WAVES 8 AIR HANDLING UNIT AHU-4000 FF-008 WAVES 9 AIR HANDLING UNIT AHU-3455 FF-009 WAVES
10 AIR HANDLING UNIT AHU-6220 FF-010 WAVES 11 AIR HANDLING UNIT AHU-1100 FF-011 WAVES
12 DEHUMIDIFIER 10 KW FF-012 FALICITY EQUIP.
13 ANALITICAL WEIGHING BALANCE AX-200 FF-013 SHIMADZU 14 STICKER LABELING M/C ASAL-250 FF-014 N.K. ENG. 15 WATER COOLER SYSTEM BDRM-1 FF-015 BLUE STAR 16 VIAL FILLING M/C VFM-150 FF-016 BHOLE TECHNO 17 VIAL SEALING M/C VSM-150 FF-017 BHOLE TECHNO 18 VIAL WASHING M/C VWM-150 FF-018 HBPL BADDI 19 AIR HANDLING UNIT AHU-800 FF-019 WAVES
SASBIOSYNTH 34
20 AIR HANDLING UNIT AHU-1350 FF-020 WAVES 21 AIR HANDLING UNIT AHU-450 FF-021 WAVES 22 AIR HANDLING UNIT AHU-1200 FF-022 WAVES 23 AIR HANDLING UNIT AHU-1350 FF-023 WAVES 24 AIR HANDLING UNIT AHU-400 FF-024 WAVES 25 AIR HANDLING UNIT AHU-2655 FF-025 WAVES 26 UV. SPECTROPHOTOMETER SL-160 FF-026 ELICO 27 TOP LOADING BALANCE BL 220H FF-027 SHIMADZU
28 PH. METER ( DIGITAL) FF-028 POPULAR ( AMBALA)
29 PH. METER ( DIGITAL) FF-029 MICROCSIL INDIA
30 CONDUCTIVITY METER FF-030 MAX ELECT. CHD.
31 K.F.TITRATOR MATIC-MD FF-031 VEEGO
32 MELTING APPARATUS FF-032 POPULAR ( AMBALA)
33 REFRECTRO METER FF-033 POPULAR ( AMBALA)
34 MUFFEL FURNACE ( DIGITAL) FF-034 POPULAR ( AMBALA)
35 WATER BATH ( DIGITAL FF-035 POPULAR ( AMBALA)
36 CERCULATING APPRATUS ( DIGITAL) FF-036 POPULAR ( AMBALA)
37 MAGNETIC STIRRER ( WITH HOT PLATE) FF-037
POPULAR ( AMBALA)
38 VACCUME OVEN ( DIGITAL) FF-038 POPULAR ( AMBALA)
39 FLOW CUP VISCOMETER FF-039 POPULAR ( AMBALA)
40 HOT AIR OVEN ( DIGITAL) FF-040 OSHO BADDI 41 TLC KIT ( WITH UV CABNET) FF-041 OSHO BADDI 42 REFRIDGERATOR FF-042 GODREGE 43 HPLC 2487 FF-043 WATER
44 WATER DISTILATION FOR HPLC FF-044 SARTHAK SCINTI.