COS-GMP Section 12 Explained: Inspections and Acceptance

By Robert Low, Lead Management System Specialist

Section 12 of COS-GMP covers inspections and acceptance — the equivalent ground to ISO 22716’s quality control laboratory section, including out-of-specification handling within the same section rather than splitting it out separately as ISO 22716 effectively does between its laboratory and disposition clauses.

This post is part of a series working through COS-GMP section by section. The series summary with links to every section is available at the end.

What the Standard Covers

General and test methods. Controls need to ensure stock items meet quality criteria at each stage of operation before release for use or shipment. Inspection activities need established test methods necessary to confirm compliance, with those methods documented to support consistent training, application, and validation.

Acceptance criteria and results. Acceptance criteria, or parameter limits, need specifying for stock items. All results need recording and reviewing, with a disposition decision following — approved, rejected, quarantined pending further consideration, pending, or disposed of. Out-of-acceptance results need reviewing by authorised personnel — Technical Compliance, development, or the customer as relevant — and properly investigating, with sufficiently recorded re-testing results if any additional testing is performed. Following investigation, a decision needs making in terms of approved, concessioned, rejected, disposed of, or pending.

Analytical materials. Reagents, solutions, reference standards, and culture media need identifying by name, strength or concentration, expiry date, the preparer’s name or initials, opening date, and storage conditions, where each is appropriate. Where these materials are prepared on site, preparation needs to follow documented procedures, supported by training records.

Sampling. Sampling needs conducting by authorised personnel only, with the process clearly defined — method, equipment, designated location, quantity, contamination precautions, identification method, and frequency. Samples need to be identifiable through a name or unique code, traceability code where applicable, sampling date, the container sampled from, and the specific sampling point where applicable.

Retain samples. Where appropriate or required by a customer, identifiable and traceable finished product samples need retaining for a defined period under recommended storage conditions in defined areas. Bulk product samples need the same treatment in appropriate containers. Sample size needs to allow analysis in line with local regulations.

Where This Commonly Goes Wrong

The most common gap mirrors ISO 22716’s equivalent finding closely — out-of-acceptance results being re-tested without sufficient recorded justification, effectively testing into compliance rather than genuinely investigating the cause of the original failure.

The second common gap is the disposition categories not being used consistently — COS-GMP draws a specific distinction between “quarantined” (potentially acceptable, pending further consideration) and “pending” (awaiting a decision more generally), and treating these as interchangeable loses some of the precision the standard intends.

How This Connects to the Rest of the System

Out-of-acceptance investigations should feed directly into nonconformance and CAPA management, with the disposition decision recorded as part of that same nonconformance record. Retain sample tracking benefits from being linked to stock and inventory management so retained samples are not accidentally treated as available stock.

This post is part of the Cornerstone COS-GMP series. See the full series summary with links to all 11 sections.