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Tag: FDA 21 CFR 211.80

Never Stack Rejected Goods in GMP Primary Warehouses

Posted on November 6, 2025November 14, 2025 By digi

Never Stack Rejected Goods in GMP Primary Warehouses Don’t Stack Rejected Goods in GMP Primary Warehouses Remember: Rejected or non-conforming materials must be stored in dedicated quarantine areas — never mix them with approved inventory in primary storage zones. Why This Matters in GMP Rejected, expired, or non-conforming products must be physically segregated to prevent…

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GMP Tips

Never Stack Drums Above Pallet Height Limits in GMP Warehouses

Posted on October 17, 2025November 14, 2025 By digi

Never Stack Drums Above Pallet Height Limits in GMP Warehouses Don’t Stack Drums Beyond Pallet Height Limits in GMP Warehouses Remember: Never exceed the prescribed pallet height when stacking drums — this avoids safety hazards, material damage, and regulatory non-compliance. Why This Matters in GMP In GMP-compliant warehouses, material storage must not only preserve quality…

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GMP Tips

Implement RFID Tracking for High-Risk Materials in GMP Supply Chains

Posted on October 13, 2025November 14, 2025 By digi

Implement RFID Tracking for High-Risk Materials in GMP Supply Chains Do Implement RFID Tracking for High-Risk Materials in GMP Operations Remember: Use RFID tracking systems for critical GMP materials — it enhances traceability, improves inventory accuracy, and minimizes mix-up risks. Why This Matters in GMP High-risk materials — including active pharmaceutical ingredients (APIs), controlled substances,…

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GMP Tips

Maintain Separate Sampling Tools for APIs and Excipients to Prevent Cross-Contamination

Posted on September 5, 2025November 14, 2025 By digi

Maintain Separate Sampling Tools for APIs and Excipients to Prevent Cross-Contamination Use Separate Sampling Tools for APIs and Excipients to Prevent Contamination Remember: Always maintain distinct sampling tools for APIs and excipients — this avoids cross-contamination and ensures material purity in GMP environments. Why This Matters in GMP Sampling is the first step in material…

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  • Never Assign Batch Release Responsibilities to Non-QA Personnel in GMP

    Never Assign Batch Release Responsibilities… Read more

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