Tag: data integrity

Do Not Include Unrelated Documents in GMP Production Records

May 7, 2025 digi

Do Not Include Unrelated Documents in GMP Production Records Keep Production Records Free of Unrelated Documents Remember: Only include relevant, approved documents in GMP production records to preserve clarity and compliance. Why This Matters in GMP GMP documentation must be organized, traceable, and limited to approved content. Inserting unrelated notes, calculations, or non-referenced documents into…

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Clean Sampling Tools After Each Use to Prevent Cross-Contamination

May 6, 2025 digi

Clean Sampling Tools After Each Use to Prevent Cross-Contamination Always Clean Sampling Tools After Every Use Remember: Clean and sanitize all sampling tools after each use to avoid cross-contamination and maintain product integrity. Why This Matters in GMP Sampling tools come into direct contact with raw materials, APIs, and intermediate products. If not properly cleaned…

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Never Approve Batches Without Complete Analytical Test Reports

May 5, 2025 digi

Never Approve Batches Without Complete Analytical Test Reports Do Not Approve Any Batch Without Full Analytical Reports Remember: Ensure all required analytical test reports are reviewed and approved before batch release. Why This Matters in GMP Approving a batch without all relevant analytical reports compromises product quality assurance and puts patients at risk. Every batch…

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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…

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Implement Controlled Access to Data Entry Terminals in GMP Areas

May 4, 2025 digi

Implement Controlled Access to Data Entry Terminals in GMP Areas Ensure Controlled Access to GMP Data Entry Terminals Remember: Only authorized personnel should access GMP data terminals using secure login credentials. Why This Matters in GMP Unrestricted or shared access to data entry terminals increases the risk of data manipulation, unauthorized changes, and loss of…

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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…

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