Mfr

DOCUMENTATION DOCUMENTATION PRACTICEPRACTICE

PRESENTED BY PRESENTED BY HARISH DHANASHREEHARISH DHANASHREE

I.M.PHARMA I.M.PHARMA DEPT OF PHARMACEUTICSDEPT OF PHARMACEUTICS

1

INTRODUCTIONDocument is a written report or record

that provides information especially of an official or legal nature.

Documentation is a method of preparing a written material, which describe the process in terms of specification, instructions etc.

2

Drug and cosmetic rules… The drugs and cosmetic rules under

the “conditions of licenses” and under schedule M require a manufacturer of drugs to maintain various records.

3

What documentation system consists…? Written specification Descriptions Procedures Instructions Observation/execution data.

4

Importance of Documentation It provides necessary working details. Reduces the risk of mistake. Help in tracing the deviation from the

expected yield. They help in decreasing the batch to batch

variation so that quality of product is kept within the limits of acceptability.

Considered as the history of batch operations.

Self-inspection of procedure.***Documentation and records are essential for obtaining accreditation,

certification of ISOs and approvals by Federal Bodies.

5

Documentation-Important Areas Particulars with respect to their storage,

stability and handling. Instruction for all manufacturing and

packaging procedure. Instruction for non-product related

operations. Procedure for testing. Specification of starting materials, packing

materials and products for the compliance by the quality control department.

6

MASTER FORMULA RECORDS

Master formula records are defined as written procedure that give the complete description of all aspects of its manufacture, packing and control with an infection to ensure the purity, identify, quality and strength of each dosage unit through its shelf life.It includes the following information,Specifying a fixed formulationIdentifying quality criteria for componentsProviding a set of manufacturing instruction in clear termsDescribing systematic sampling proceduresListing precise assays, tests etc.Establishing methods for ensuring complete accountability for all materials Including packing and labelling.

7

Types of Master Formula Records

The master formula records give proportion of ingredients in the formulation.

Master batch formula records, which specify absolute amounts of specific potent ingredients and excipients.

8

MASTER PRODUCTION AND CONTROL RECORDS

Master production and control records are defined as detailed written instructions including all operations starting from dispensing of raw materials till finishing of bulk products and packaging operation of a particular product.

Master production and control record includes batch size, date of manufacture and full signature (hand written) by one person and further independently checked, dated and signed by second person.

9

SEQUENCE OF 9 SUBSECTION10

11

BATCH PRODUCTION AND CONTROL RECORDS

12

Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch.

These records shall include: (a) An accurate reproduction of the appropriate

master production or control record, checked for accuracy, dated, and signed;

(b) Documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished.

BATCH PRODUCTION AND CONTROL RECORDS

13

Dates; Identity of individual major equipment and lines used; Specific identification of each batch of component or in-process

material used; Weights and measures of components used in the course of processing; In-process and laboratory control results; Inspection of the packaging and labeling area before and after use; A statement of the actual yield and a statement of the percentage of

theoretical yield at appropriate phases of processing; Complete labeling control records, including specimens or copies of all

labeling used; Description of drug product containers and closures; Any sampling performed; Identification of the persons performing and directly supervising or

checking each significant step in the operation; Any investigation made according to. Results of examinations made in accordance with.

RAW MATERIALS14

The schedule U to the drugs and cosmetic rules require following particulars to be shown in the raw material records:-

Date of receipt, Invoice number, Name and address of manufacturer/supplier, Batch number, Quantity received Pack size, Date of manufacture, Date of expiry Date of analysis and release/rejection by quality control, Analytical report number, Quantity issued, Date of issue, Name and batch number of the product for manufacture of which

issued, Proper disposal of stocks

FORMAT15

Date of receipt

Invoice number & date

Name &Address

of supplier

QtyRecd(pack size)

B. No.

Mfgdate

Expdate

Name &Address of manufactur

er

OpinionOf Q.C.Dept

QCReportNo.& Date

Name of the material:

RECEIPT

DateOf

IssueQty

issuedName & B. No.of product forwhich issued

BalanceParticulars of disposal if not

usedSign of issuing

person

ISSUE/DISPOSAL

Labels and printed packaging material records

16

The Indian GMPs require the records of labels and printed packaging materials indicating receipt, examination relating to testing and whether accepted or rejected to be maintained.

Labels What must be labelled?

-Containers, equipment, premises, products, intermediates, samples, standards etc.-Status (quarantined, accepted, rejected, clean)

Who has responsibility for labelling?-QC and production for status labels-Final product, intermediates, reagents etc.

Drug product container, closure, and labelling records.

17

These records shall include the following: The identity and quantity of each shipment of each lot

of components, drug product containers, closures, and labelling.

The results of any test or examination performed. An individual inventory record of each component,

drug product container, and closure and, for each component, a reconciliation of the use of each lot of such component.

Documentation of the examination and review of labels The disposition of rejected components, drug product

containers, closure, and labelling.

Drug product container, closure, and labelling records.

18

Date of receipt

Qty received

Invoice No Date, name &address

Consignmentnumber

Opinion of Q.C

Q.C. report No & date

Date Of issue

Qty issued

Batch .No for which issued

balance Particulars of disposal if not used

Sign of issuing person

Name of the material:

RECEIPT

ISSUE /DISPOSAL

QUALITY CONTROL RECORDS:

19

The quality control records must show:

The date of performance of test; Identification of material; Name of supplier(in case of raw materials) Date of receipt Batch number Quantity received (in case of raw materials)

(batch size in case of finished product) Date and quantity of sample taken Specifications employed for testing

20

All data secured in the course of each test including all graphs, charts, printouts etc

Calculations performed in connection with including units of measures, conversion factors and equivalence factor

A statement of the result of tests and how the results compare with established standards of identity, purity and strength

The initials or signature of person who performs the tests Certificate number issued Disposition of the quality control unit accepting or

rejecting the material.

REFERENCE21

Good Manufacturing Practice, Quality Control Guidelines, Basic Standard In the Manufacture Of Drugs Pharmaceuticals Companion Volume to Handbooks Of Drug Laws - By M.L. Mehra.

How to practice GMPs P.P.Sharma. Pharmaceutical Production And

Management, CVS subrahmanyam.

22

THANK THANK YOUYOU