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Tag: quality assurance

Conduct Risk Assessments Before Implementing Process Changes

Posted on May 1, 2025 By digi

Conduct Risk Assessments Before Implementing Process Changes Ensure Risk Assessment Precedes Any Change in Manufacturing Process Remember: Never initiate process changes without first conducting a documented risk assessment. Why This Matters in GMP In the pharmaceutical industry, even minor changes to a manufacturing process can have significant consequences. A change that appears harmless may introduce…

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GMP Tips

Conduct Risk Assessments Before Implementing Process Changes

Posted on May 1, 2025 By digi

Conduct Risk Assessments Before Implementing Process Changes Ensure Risk Assessment Precedes Any Change in Manufacturing Process Remember: Never initiate process changes without first conducting a documented risk assessment. Why This Matters in GMP In the pharmaceutical industry, even minor changes to a manufacturing process can have significant consequences. A change that appears harmless may introduce…

Read More “Conduct Risk Assessments Before Implementing Process Changes” »

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quality assurance

  • Do Not Stockpile Rejected Units in Pharmaceutical Dispensing Areas
  • Never Use Photocopies as Originals for GMP Quality Documents
  • Verify Integrity of Tamper-Evident Seals During Packaging
  • Never Rely on Memory to Record GMP Observations or Results
  • Never Discard Rejected Materials in General Trash Bins
  • Never Replace Approved SOPs with Verbal Instructions in GMP
  • Do Not Include Unrelated Documents in GMP Production Records
  • Clean Sampling Tools After Each Use to Prevent Cross-Contamination
  • Never Approve Batches Without Complete Analytical Test Reports
  • Verify Batch Yield Calculations Before Finalizing Manufacturing Records

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