Tag: QA oversight

Do Not Stockpile Rejected Units in Pharmaceutical Dispensing Areas

May 18, 2025 digi

Do Not Stockpile Rejected Units in Pharmaceutical Dispensing Areas Rejected Units Must Not Be Stored in Dispensing Areas Remember: Rejected materials should be promptly removed from dispensing areas to prevent mix-ups, cross-contamination, or unauthorized usage. Why This Matters in GMP Dispensing areas are reserved for handling approved materials that meet all quality specifications. Keeping rejected…

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Update GMP Training Records After Every Training Session

May 17, 2025 digi

Update GMP Training Records After Every Training Session Always Update Training Records Immediately After GMP Sessions Remember: GMP training records must be filled out, signed, and filed after each session—this is critical for compliance and personnel qualification. Why This Matters in GMP Personnel training is a cornerstone of GMP compliance. Accurate and up-to-date training records…

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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…

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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…

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Never Mix Product Labels from Different Batches in the Packaging Area

May 8, 2025 digi

Never Mix Product Labels from Different Batches in the Packaging Area Prevent Mixing of Product Labels in Packaging Rooms Remember: Never allow different product or batch labels to coexist in the same packaging area — always ensure strict segregation. Why This Matters in GMP Packaging is a critical control point in pharmaceutical manufacturing, and label…

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