FDA 21 CFR 211.80 – Pharma GMP

Never Stack Rejected Goods in GMP Primary Warehouses

digi — Thu, 06 Nov 2025 11:13:27 +0000

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...

Never Stack Drums Above Pallet Height Limits in GMP Warehouses

digi — Fri, 17 Oct 2025 11:00:55 +0000

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...

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

digi — Mon, 13 Oct 2025 23:25:07 +0000

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,...

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

digi — Fri, 05 Sep 2025 04:54:33 +0000

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...