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