Tag: good documentation practices

Do Not Record Test Results Before Completing the Analysis

May 11, 2025 digi

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…

GMP Tips

Avoid Manual Data Corrections Without Proper Justification

May 9, 2025 digi

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…

GMP Tips

Label In-Process Samples with Date and Initials for Traceability

May 5, 2025 digi

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…

GMP Tips

Avoid Operating Equipment Without Completing Logbook Entries

May 2, 2025 digi

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…

GMP Tips