Good Documentation Practice and Document Control in Pharmaceuticals

One of the key elements of the quality system is Good Documentation Practice (GDP). GDP plays a very vital role in ensuring compliance in Good Manufacturing Practice (GMP) environment. The purpose of documentation and recording is to ensure that activities impacting the product quality will control and track. These activities may or may not directly affect product quality, but it is in the purview of the GMP system as directed by regulations. Instructions and Records are two main categories of documents used in the GMP environment.

The essential requirement of documentation is it should abide by the ALCOA++ principle.
Ω Attributable
Ω Legible
Ω Contemporaneous
Ω Original
Ω Accurate
Ω Complete
Ω Consistent
Ω Enduring
Ω Available
The above principle applies to all types of documents, including paper-based, electronic, or photographic media.

Good Documentation Practice and Document Control in Pharmaceuticals

1. Types of records

a. Instructions (directions, requirements)

  1. Specifications
  2. Manufacturing Formulae, Processing, Packaging, and Testing Instructions
  3. Procedures
  4. Protocols
  5. Technical Agreements

b. Records/ reports:

  1. Records – Activities, events, investigations, manufacturing record of each batch, distribution record, raw data of analysis, log books.
  2. Certificates of Analysis – Testing results in summarized form and evaluation results against approved specification.
  3. Reports – Detailed information regarding activities performed under approved protocol or procedure. These could be an investigation report, study report with recommendation and conclusion, development report etc.

2. Key elements of creation and control of documents:

  • Consistency in format and design
  • Procedure based
  • Documents shall have clearly stated title, objective, and scope.
  • Prepared, checked, and approved by authorized individuals. Clear definition of ‘prepared by’, ‘checked by’, ‘reviewed by’, ‘verified by’, and ‘approved by’.
  • The Current version of document availability all the time and retrieve obsolete document immediately.
  • The integrity of the document throughout its lifecycle.
  • An imperative mandatory style should be used to write work instructions and procedure.
  • Regular review of a document with a predefined frequency.
  • Controlled distribution – Reproduction of copies should be under authorized control.
  • Each document must have a unique identification document number, revision date, approval date, and effective.
  • Page numbering on each page with a total number of pages (e.g. Page 2 of 30).
  • Explain abbreviations in the same document. The best approach is to specify the meaning of the abbreviation for the first time when is used.
  • Provide reference of guidelines, references procedure, or relevant documents.
  • Standardize format for date and time.

3. Good Documentation Practice in pharma:

a. Dos:

  1. Entry must be clear, legible, and with indelible ink
  2. Contemporaneous entry.
  3. Specify the unit of measurement while entering values (as applicable).
  4. Logbooks entries in chronological order
  5. Documents with signed and dated.
  6. Blank/ unused space struck through with a single line with signature and date.
  7. Specify ‘Not Applicable’ as appropriate.
  8. Use valid signature (Registered in organization’s GMP record as a specimen signature).

b. Don’ts:

  1. Overwriting
  2. Use of white ink, correction fluid or sticky notes, scratch papers, loose papers
  3. Ditto, as above
  4. Shortcuts to record entries, e.g., OK, Done
  5. Bracketing for multiple entries
  6. Pre-dating or post-dating
  7. Stamp as a signature

c. Correction of entries:

  1. Any alteration/correction of manual entries shall with sign, date, and reason for correction. The reason for the change should have supporting evidence and traceability.
  2. Error rectification procedure should be in place for correction to the approved document and master documents.
  3. Missing entry for non-retrieval data shall be handled using deviation handling process.
  4. Missing entry or signature require traceability concerning activity execution and person.
  5. Entry error or transcription error in electronic document require appropriate documentation and justification.

d. Cancellation of documents/ entries:

  1. Cancellation of a document should be handled through a change control system.
  2. Any cancelation of the executed document should have proper justification and traceability.

e. Handling missing document:

  1. In case of a document found missing, it is required to be handled through a non-conformance handling procedure.
  2. In case of supporting evidence/ raw data, true copies are available for missing document; it shall be reviewed and retained as a supporting document in the absence of the original document.

f. Handling damaged document:

  1. It is prudent to ensure that documents are handled carefully and to eliminate every potential damage to documents. In case of any document is found damaged; however, information is not lost; it should be fixed using transparent tape to safeguard it. A photocopy can be attached with the appropriate authorization for future reference.
  2. Master document: If the master document is found damaged, control copies of the document can be retained for future use and a damaged copy of the master document for future reference. Appropriate documentation and authorization are required.
  3. Control copy of the document: In case of control copy of the document is found damaged, a new control copy of the document can be issued in replacement of the damaged copy.
  4. Reports: In the case of the report found damaged and data is not readable, new reports can be generated using if raw data are available. Non-conformance is required to be recorded.
  5. Raw data found damaged: Non-conformance needs to be recorded. If supporting information and approved reports are generated from the original data, the data can be used as supporting information.
  6. The impact of the damaged document needs to be assessed concerning product quality and patient safety.

g. The retention period for documents:

  1. Pre-define the period for document retention of various types of documents.
  2. The typical retention time for batch-related documents is expiry + one year or five years, whichever is more.
  3. Retention of documents in such a way that it should be easily retrievable and within a specified time.
  4. Validation documents are expected to be retained up to the lifecycle of the product. This means that all applicable documents shall be retained up to the last marketed batch expiry + one year or five years from the last batch manufactured, whichever is longer.
  5. Equipment qualification documents are expected to be retained up to the lifecycle of the equipment. It is expected that the document shall be retained considering the last batch manufactured on the equipment. Refer pint ii. of this section.
  6. The retention period of documents is defined in different regulatory guidance such as EudraLex Volume 4, 21 CFR Part 211, etc.
  7. In case of organization uses a third-party storage facility for document storage, an appropriate quality agreement should be established concerning document safety, security, and timely retrieval conditions.

h. Destruction of documents:

  1. The documents can be destroyed only after a defined retention period is over.
  2. The destruction of the document shall be done using an approved procedure and with quality unit authorization.
  3. The procedure shall be established to destroy draft documents, which could be generated daily as part of the document creation and review process. Appropriate review and authorization mechanisms shall be put in place to destroy such draft documents to ensure that no controlled, master document or original reports could be destroyed inadvertently or because of any reason.
  4. In-process labels, labels used during analytical testing that do not require storage after use, shall be destroyed by defacing it as per the organization’s approved procedure.

4. References

a. EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines

b. 21 CFR Part 211

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