good documentation practices – Pharma GMP

Never Use Volatile Markers on GMP Documents to Prevent Data Integrity Risks

digi — Wed, 06 Aug 2025 08:28:23 +0000

Never Use Volatile Markers on GMP Documents to Prevent Data Integrity Risks Avoid Using Volatile Markers on GMP Documents to Maintain Integrity Remember: GMP documentation must be indelible, permanent, and traceable—using volatile or erasable markers compromises data integrity and violates regulatory expectations. Why This Matters in GMP Good documentation practices (GDP) are foundational to GMP...

Do Not Record Test Results Before Completing the Analysis

digi — Sun, 11 May 2025 16:14:53 +0000

Do Not Record Test Results Before Completing the Analysis Record Test Results Only After Full Completion of Analysis Remember: Entering test results before completing the entire analysis violates data integrity and can mislead quality decisions. Why This Matters in GMP Premature documentation of test results is a critical GMP violation. Such entries misrepresent the actual...

Avoid Manual Data Corrections Without Proper Justification

digi — Fri, 09 May 2025 20:05:51 +0000

Avoid Manual Data Corrections Without Proper Justification Never Perform Manual Data Corrections Without Justification Remember: All corrections to GMP data must be explained, signed, dated, and reviewed — never make undocumented changes. Why This Matters in GMP In regulated environments, every data entry is subject to traceability and verification. Manual corrections without justification raise serious...

Label In-Process Samples with Date and Initials for Traceability

digi — Mon, 05 May 2025 04:24:04 +0000

Label In-Process Samples with Date and Initials for Traceability Always Label In-Process Samples with Date and Initials Remember: In-process samples must be clearly labeled with the sampling date and initials of the person who collected them. Why This Matters in GMP In-process samples provide real-time insight into product quality at different stages of manufacturing. Without...

Avoid Operating Equipment Without Completing Logbook Entries

digi — Fri, 02 May 2025 12:29:43 +0000

Avoid Operating Equipment Without Completing Logbook Entries Never Use Equipment Without Properly Completing Its Logbook Remember: Equipment must not be operated unless logbook entries for prior and current usage are accurately recorded. Why This Matters in GMP In GMP-compliant environments, every piece of equipment has its own identity and operational history. Equipment logbooks serve as...