Problem 6: Good Documentation Practices in Drug Manufcaturing

Various types of documentation used in manufacturing events

How to ensure the safety and efficacy of drug products:
Responsibility of production department: Need to ensure that the number of materials used are consistent to ensure efficacy of drug
Responsibility of QC department:
ensure that the materials received are of good quality and meet the specifications of the supplier
Discipline at workplace:
-Use current SOPs as working instructions
-Adhere to SDS
-Wear PPE
-Practice good record keeping
-Prevent cross contamination
Review
-Review all records and reports of production
-Person of a higher authority from the same department should always verify and approve the documents

Lab testing report

Difference between BPR & MPR?

Batch Production Record (BPR)

Importance of documentation in drug manufacturing

Batch production Record

Master Production Record

Why need to document?

Production of drug formulation shall be documented and approved before it can be released for further processing

1) The Batch Record is where operators record specific lot numbers as well as the specific weights, measure or count of ingredients and components actually used to produce each batch.


BPR covers only information generated from one/each batch of the drug product produced.

2) BPR typically used and completed by the quality control (QC) department to compare their test results to specifications to determine if they pass the test.


It is prepared/filled in by all operation personnel for each batch of drug product produced (e.g. The one in- charge of the drug production stages will fill up the MBR.)

What is BPR?
Batch production and control records are prepared for each batch of drug product produced.

1) MPR covers complete instructions of production and control of drug production


*THERE IS ONLY 1 MASTER COPY (MPR) → FROM HERE YOU USE BPR TO TAKE REFERENCE FROM THE MPR

2) MPR is assembled in one document and managed by QA

Out - of - Specification (OOS) investigation report

Master Production Records

What is MPR

Why is it important

Set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls



Complete instruction for production and control of drug production


  • covers complete instructions of production and control of drug production.
  • is a master copy of production and shall be referred by operation personnel when running a production.
  • is assembled in one document and managed by the QA.

Why is it important?
It summarizes how each batch of production was prepared including starting materials, processing stages, sampling and inspection results, packaging and labelling

Components: 1) Production(FDA 21 CFR Part 211.192)
2) Control (FDA 21 CFR Part 211.186)

Things to be documented:

Test name
Test results (inclu. units of measure)
Interpretation
Reference intervals
Any comments or qualifying statements
Date completed / or reported
Person reporting

What happens if information found in BPR is incomplete?Escalation to supervisors → inform them about the discrepancies → investigate through a whole load of process
( recommended to try to resolve it yourself first.)

Used for: Testing purity, Microbial count identity

Master Production Record (orange branch)

Batch Production Record (orange branch)

When: : Used before, during and after batch manufacturing process

Things to be documented:
ALL test results that did not meet the specifications or acceptance criteria established from the MPR

Used for: Investigation for deviation (discrepancy / unexplained failure

Document the specific information for each batch

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Document what is needed for all proper ingredients are added, each process step for an established procedure for all formulations and batches

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