EU GMP Chapter 4 - Documentation

What it says

Good documentation practice is essential to quality assurance, requiring documents to be designed, prepared, reviewed and distributed with care, clearly written, regularly reviewed and kept up to date, with specific requirements for batch documentation, specifications, and retention periods.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Chapter 4 consolidates documentation expectations spanning what the US framework distributes across several provisions, including elements of 211.100, 211.188 and 211.194, into a single comprehensive documentation chapter.
• Data integrity principles, closely aligned with ALCOA+, are explicitly embedded within this chapter's documentation expectations, connecting good documentation practice directly to data reliability.
• This chapter's scope covers the full documentation lifecycle: creation, review, approval, distribution, and eventual retention or destruction, treated as one integrated system rather than separate document types managed independently.

What inspectors look for

• Whether documentation practices across different document types, specifications, batch records, procedures, reflect consistent data integrity principles.
• Whether document review and approval genuinely occurs before use, with evidence of substantive review rather than pro forma sign-off.
• Whether documentation retention periods and destruction practices are controlled and defensible.

Related regulations