Raw Material Receipt

Receipt is the GMP-controlled handover from logistics to the regulated material system. 21 CFR 211.82 requires that each lot of components be examined upon receipt for appropriate labelling as to content, identity and damage to containers or any other condition that might adversely affect the quality of the component. EU GMP Chapter 5 (clauses 5.27–5.31) and ICH Q7 §7.20 carry the same requirement. The act of receipt creates the in-system lot, links it to the PO and supplier, and starts the clock on every downstream control.

• Physical inspection of containers — count, labels, integrity, tamper-evidence, temperature data loggers for cold chain.
• Document check — supplier CoA, packing list, customs paperwork, transport conditions records.
• Identity confirmation against the PO and the material master.
• Assignment of an internal lot ID (often distinct from supplier lot for namespace cleanliness).
• Placement under quarantine status pending QA-approved sampling and testing.

• Goods Receipt Note (GRN) — formal acknowledgement of receipt; basis for supplier invoice and inventory increment.
• Internal lot record — links internal lot ID to supplier lot, PO, GRN, container count, storage location.
• Inspection record — checklist results, photos of any damage, deviation linkage.
• Quarantine label — physical label placed on each container until QA disposition.
• Audit trail entries — every system action attributed to the receiver under Part 11.

Receipt is not full QC release. Identity confirmation (often a single ID test like NIR or FTIR per container under USP <1119> or Ph. Eur. 2.2.40) is part of the post-receipt sampling activity in many sites; full conformance against the material spec follows. The receipt step verifies that what arrived corresponds to what was ordered and what the CoA describes — not that it meets every specification limit.

• Accepting material with a missing or unsigned CoA — auditor's first finding every time.
• Failing to log temperature excursions on cold-chain deliveries — invalidates downstream testing.
• Reusing supplier lot numbers as internal lot IDs — collisions across suppliers; namespace pollution.
• Releasing material from quarantine before QA sampling and disposition — straight 483.
• No physical segregation of quarantined material from released stock — cross-contamination risk and warehouse-management failure.
• Treating receipt as a logistics function rather than a GMP-controlled activity — receivers untrained, records inadequate.

• Pharma APIs — 100% identity per container per ICH Q7 §7.30; CoA + supplier audit history checked at receipt.
• Biopharma raw materials — cold-chain validation, animal-origin declarations and TSE/BSE certificates verified at receipt.
• Medical device components — DHF traceability begins at receipt; supplier change-notification linkage checked.
• Food ingredients — allergen status, country of origin and HACCP-critical attributes verified at the dock.
• Cosmetics ingredients — INCI name confirmation, MoCRA-aligned supplier traceability documentation.
• Cannabis cultivation inputs — METRC-compatible lot capture, pesticide residue documentation at receipt.