3 minute read
COS-GMP
By Robert Low, Lead Management System Specialist
Section 9 of COS-GMP covers purchasing and goods intake — the equivalent ground to ISO 22716’s raw materials and packaging materials section, though COS-GMP separates the supplier approval and purchasing controls into the broader Section 5 covered earlier in this series, leaving this section focused specifically on the physical intake and release process.
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.
General. Verification of received items and services needs performing in line with a documented procedure, with purchased stock items verified as conforming to requirements through a specification outlining the requirement and acceptance criteria before use.
Goods intake. The purchase order, delivery note, and delivered materials all need to match. The integrity and acceptance criteria of stock items need comparing against the specification before release, with additional transport checks where necessary. Materials showing defects that might affect finished product quality need holding pending a decision. Materials need identifying according to status — hold pending release, released, quarantined pending investigation, or rejected — with other systems permitted if they provide the same level of assurance.
Traceability identification. Containers of raw materials and packaging materials need labelling to identify the material and batch information clearly.
Release. A documented system needs to ensure only released stock items are used, with release carried out by authorised Technical Compliance personnel or their deputy — explicitly allowing for deputisation, which matters for continuity when the primary authorised person is unavailable.
Water as a stock item. This sub-section is distinct and detailed. Where water is produced on site through a treatment system, documented controls need to support production of potable water at a defined quality level, verified through testing or process parameter monitoring, with records and acceptance criteria maintained. The treatment equipment needs setting up to avoid stagnation and contamination risk, and needs to permit sanitisation. Materials used in the treatment equipment need selecting to ensure water quality is not affected. Where water is purchased rather than produced on site, the standard’s general raw material purchasing requirements apply instead.
The most common gap is the status identification system for incoming materials not being consistently applied — particularly the distinction between “hold pending release” and “quarantined pending investigation of an issue,” which are different statuses with different implications, but which get treated interchangeably in practice at many sites.
The second common gap, specific to sites producing their own water, is the documented control and acceptance criteria for water quality being thinner than the standard expects — water often gets treated as a utility rather than a stock item requiring the same rigour as any other raw material, despite the standard explicitly framing it that way.
Goods intake and release status connect directly to stock and inventory management, where released, quarantined, and rejected status needs to be a structural distinction the system enforces rather than a label that can be overridden informally. Supplier-related quality issues identified during intake should flow into supplier monitoring as part of ongoing performance tracking.
This post is part of the Cornerstone COS-GMP series. See the full series summary with links to all 11 sections.
Back to all
