Tag: quality assurance

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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Never Use Photocopies as Originals for GMP Quality Documents

May 17, 2025 digi

Never Use Photocopies as Originals for GMP Quality Documents Do Not Use Photocopies as Original GMP Quality Documents Remember: Only approved, controlled originals should be used for GMP activities—photocopies are not acceptable as quality documents. Why This Matters in GMP Using photocopied documents introduces the risk of working with outdated, unauthorized, or modified content. Without…

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Verify Integrity of Tamper-Evident Seals During Packaging

May 16, 2025 digi

Verify Integrity of Tamper-Evident Seals During Packaging Check Tamper-Evident Seals for Integrity During Packaging Remember: Tamper-evident seals must be visually verified during packaging to ensure they are applied correctly and uncompromised. Why This Matters in GMP Tamper-evident packaging is a vital mechanism for protecting pharmaceutical products against manipulation and counterfeiting. These seals serve as visible…

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Never Rely on Memory to Record GMP Observations or Results

May 14, 2025 digi

Never Rely on Memory to Record GMP Observations or Results Document Observations Immediately—Don’t Rely on Memory Remember: All GMP observations and results must be recorded contemporaneously—memory is not a valid data source. Why This Matters in GMP In GMP environments, every observation, measurement, or deviation must be documented at the time it occurs. Delayed entries…

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Never Discard Rejected Materials in General Trash Bins

May 13, 2025 digi

Never Discard Rejected Materials in General Trash Bins Rejected Materials Must Not Be Thrown into General Waste Bins Remember: Discarding rejected materials in general trash is a serious GMP violation—use designated, controlled disposal procedures. Why This Matters in GMP Rejected pharmaceutical materials, whether due to contamination, deviation, or quality failure, must be handled with utmost…

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Never Replace Approved SOPs with Verbal Instructions in GMP

May 8, 2025 digi

Never Replace Approved SOPs with Verbal Instructions in GMP Follow Approved SOPs—Never Use Verbal Instructions in GMP Remember: Verbal instructions must not replace approved SOPs in any GMP-regulated activity. Why This Matters in GMP Standard Operating Procedures (SOPs) are the backbone of GMP compliance. They ensure consistency, reproducibility, and control across all operations. When personnel…

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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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Verify Batch Yield Calculations Before Finalizing Manufacturing Records

May 3, 2025 digi

Verify Batch Yield Calculations Before Finalizing Manufacturing Records Always Verify Batch Yield Calculations Before BMR Finalization Remember: Confirm all yield values before signing off on the Batch Manufacturing Record (BMR). Why This Matters in GMP Yield reconciliation is a critical component of GMP manufacturing that ensures raw materials are efficiently converted into finished products. Yield…

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