GMP module 02 - Good Documentation Practice

Outcome of the Module:

After completing this module, you will be able to:

  • Recognize the importance of procedures
  • Recognize the importance of record keeping
  • Identify the possible consequences of not completing and certifying GMP documents
  • Identify how to complete batch records and associated supporting documents

 

Part I – Need for Documentation

Manufacturing instructions should clearly and accurately define each manufacturing process step. Production operators should rely upon following these approved steps of manufacture, not draft instructions. GMP rules do not allow companies to use draft, trial or out-of-date documents in commercial manufacture. The instructions, however, should be based on experience with completing the tasks. If problems arise, the procedures should be revised to reflect exactly what is required. 

GMP regulations require that manufacturers comply with some very important manufacturing principles. One of these principles addresses the need for documentation and traceability.  

Regulations require manufacturers to keep many records, including records for:

  • Raw materials
  • Packaging materials
  • Manufacturing
  • Quality control testing
  • Finished product distribution
  • Incidents and devotions
  • Complaints

 

Documentation allows an investigation, if required, into the manufacture of the batch. It also allows traceability to where the products were sent. A compliant documentation system should:

  • Have written procedures that are well-defined, understood and
  • Prevent misinterpretation and error
  • Be unambiguous
  • Have accurate records that provide evidence of performance
  • Allow calculations to be checked
  • Allow tracing of a batch history, in some situations, over months or years

 

Batch records must be stored safely, and must be able to be relieved when necessary.

Part II – GMP Documentation

Completed batch records must accurately reflect what actually happened during manufacture and packaging. Once the product leaves the warehouse, only the batch and test records remain as evidence of good manufacturing practice. If there is an error in the record, particularly if it relates to a formulation, should be formally investigated as soon as possible.

Waiting to see if the GMP auditors find it misses the point, as it may delay recovery or correction of a significant safety problem. To ensure consistent quality of materials and product, there are written specifications for all:

  • Starting materials
  • Packaging materials
  • Intermediate products
  • Finished products

Specifications need to be approved by the Quantity Department, and are not to be changed without their written approval. Starting materials are purchased only from approved suppliers and to authorized specifications. Each separate material is given a Unique Identifying Number (UIN) from the Goods Received Register.  

The UIN and the standard name are used throughout manufacturing to identify that material and to trace its history from supplier to customer.

  • Goods Received Register
  • Standard Names List
  • Status labels
  • SOPs and Work Instructions

 

Part III – Record Keeping

Master processing instructions are probably the most critical documents in the plant. They provide the official registered, validated, company-approved instructions, and as such ensure product safety and compliance. Failure to follow the current instructions could lead to defective product, possible recalls, and harm to patients. Product manufactured not in compliance with the government-resisted details is against the law.

It is never permissible to hold unofficial photocopies of master instructions for convenience. One only approved copy of the current, approved master instruction should be released each time a batch is to be prepared, because from time to time these instructions are updated to a new version.

Part IV – Good Documentation Practices

Recording information in the document itself

  • Only permanent ink, preferably blue or black, should be used to complete a document.
  • Red ink might be used to highlight proposed changes in a document. All recorded information should be clear, legible, and accurate.
  • Using a white correction fluid or writing over an entry to correct an error is not acceptable.
  • If a correction is necessary, the incorrect information should be crossed out using one line.
  • The correct information should be entered near the incorrect information accompanied by the initials of the person making the correction and the date the correction was made.
  • If repeated information is required for several lines in a document, e.g., initials, no ditto marks (“) or arrows () should be used. Initials should be entered each time they are required.

 

Recording data:

All data should be recorded directly onto the production batch record, appropriate record, logbook, form or worksheet. Errors, which are corrected based on information contained in another source document, must be referenced or the source document must be attached. Personnel who verify calculations must do so independently.

Conclusion:

  • A good documentation system is the cornerstone of a GMP compliance system.
  • All personnel must follow the written and approved documents in the day-to-day operation of the manufacturing facility.
  • It is the responsibility of management to provide a documentation system that conforms to the GMP requirements, and then train the users in the requirements of the system.
  • It is your responsibility to understand the documents and use them correctly. When you sign or initial a record saying that you carried out a process, you are certifying that the process was carried out according to the written and approved procedures.
  • When you sign or initial a checking step in a record, you are saying that you observed what was done, and can verify that it was done correctly.
  • It is only by having a documentation system that everyone complies with, that we can demonstrate that we have manufactured a quality product. Remember: if it’s not documented, it wasn’t done.

 

Cleanrooms and cross-contamination

Online Quiz:

  • Number of questions: 10
  • No time limit
  • Allow you save and finish at a later date
  • Allow you to go back and change your answer
  • Attempting each question is mandatory
  • Pass mark at and above 70%
  • Print results and certificates
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