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Tag: audit readiness

Label In-Process Samples with Date and Initials for Traceability

Posted on May 5, 2025 By 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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GMP Tips

Avoid Operating Equipment Without Completing Logbook Entries

Posted on May 2, 2025 By 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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GMP Tips

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  • Monitor Utility Systems Like Water and Compressed Air for GMP Quality

    Monitor Utility Systems Like Water… Read more

audit readiness

  • Update GMP Training Records After Every Training Session
  • Never Use Photocopies as Originals for GMP Quality Documents
  • Conduct Routine Gown Integrity Checks in GMP Cleanrooms
  • Review Equipment Logbooks for Completeness During GMP Audits
  • Never Rely on Memory to Record GMP Observations or Results
  • Never Discard Rejected Materials in General Trash Bins
  • Do Not Record Test Results Before Completing the Analysis
  • Never Replace Approved SOPs with Verbal Instructions in GMP
  • Do Not Include Unrelated Documents in GMP Production Records
  • Conduct Periodic Pest Control Audits in GMP Storage Areas

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