Good documentation practice is a crucial component of GxP compliance. Good Documentation Practices should be applied whenever you are writing, preparing, completing, reviewing, filing, archiving, or disposing of documents used for or in support of any activity related to the production or manufacture of regulated products.
In other words, GDP or GDocP or GdP should always be applied when handling "controlled documents".
Commissioning and Qualification (C&Q) is inherently a documentation based activity and has many good documentation practices imbedded in the process so it is standardized and repeatable.
For C&Q projects specifically, good documentation practices should be applied to the following documentation activities and scenarios:
Data Entry
- Document at time of performance, no backdating
- Make legible entries with use of blue or black ink, no pencil
Signatures
- Maintain a master initials/signature log
- Use initials or full signatures as required by the document
Date and Time
- Use preferred date format i.e. DDMMYY or DDMMMYY
- Record time in 24hr format i.e. 1300 for 1:00 PM
Corrections
- Single line through original text with signature and date
- Corrections made by individual responsible for the original
Late Entries
- Explain why entry was not made originally
- Supply supporting evidence
Numerical Data
- Use significant digits required by the document or provided by the instrumentation
- Round according to document instructions
Units of Measure
- Always include units
Attachments
- Note on primary document that attachments are included
- Initial and date all attachment pages
Labels
- Affix to document
- Initial and date
Transcription
- Cross through original document, initial and date
- Attach original to new, sign and date, provide explanation
Copies
- “Copy” to be handwritten or stamped on each page
- Initial and date every page
True & Exact Copies
- Must be stamped or handwritten on each page
- Must have initials and date, reference to original location
Approvals
- Document revisions require the same approval matrix as original
- Documented designee when original approver not available
Archiving & Retention
- Archive in controlled environment
- File for easy retrieval
Resource Person: Nathan Roman
