material segregation – Pharma GMP

Clearly Define and Label Quarantine Area Boundaries in GMP Warehouses

digi — Wed, 10 Sep 2025 07:22:10 +0000

Clearly Define and Label Quarantine Area Boundaries in GMP Warehouses Clearly Label Quarantine Boundaries in GMP Warehousing Zones Remember: Always identify and demarcate quarantine areas — it prevents the unintentional use of untested or unapproved materials in GMP operations. Why This Matters in GMP Quarantine areas in GMP warehouses are designated for materials that have...

Don’t Accumulate Discarded Packaging in GMP Production Areas

digi — Fri, 18 Jul 2025 16:39:25 +0000

Don’t Accumulate Discarded Packaging in GMP Production Areas Do Not Allow Discarded Packaging to Accumulate in Production Zones Remember: GMP requires timely removal of packaging waste from production areas to prevent contamination, product mix-ups, and material flow disruptions. Why This Matters in GMP During packaging operations, rejected labels, empty cartons, defective blisters, and overprinted materials...

Quarantine Returned Goods with Clear Identification Labels

digi — Wed, 28 May 2025 15:51:18 +0000

Quarantine Returned Goods with Clear Identification Labels Returned Goods Must Be Quarantined with Proper Labels Remember: Always isolate and clearly label returned goods—this prevents mix-ups and ensures GMP-compliant disposition decisions. Why This Matters in GMP Returned pharmaceutical goods—whether from customers, distributors, or hospitals—pose potential risks due to unknown storage conditions, damage, or expired status. Placing...

Do Not Store API Drums Directly on the Floor in GMP Warehouses

digi — Sun, 04 May 2025 14:28:01 +0000

Do Not Store API Drums Directly on the Floor in GMP Warehouses Always Use Pallets—Never Place API Drums Directly on the Floor Remember: API drums must be stored off the ground on clean pallets or designated racks to prevent contamination and maintain GMP compliance. Why This Matters in GMP Storing Active Pharmaceutical Ingredient (API) drums...