3 minute read
COS-GMP
By Robert Low, Lead Management System Specialist
Section 10 of COS-GMP covers production — bulk manufacturing operations and filling and packaging operations together in one section. The structure closely follows ISO 22716’s equivalent sections, with one consistent terminology shift worth noting: COS-GMP uses “traceability code” throughout, rather than “batch number,” reflecting its broader scope across product categories beyond traditional cosmetics.
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.
Relevant documentation needs to be available at each manufacturing stage, including suitable equipment recorded on works orders for traceability, the bulk product formula, a list of raw materials with traceability codes and required quantities, and a detailed method of manufacture for each stage.
Before starting, records need confirming that documentation is available, raw materials are available, within their re-evaluation period, and released, equipment is suitable and appropriately cleaned, and the area is clear of non-specified materials from the previous operation. A traceability code gets assigned to each batch of manufactured bulk product. Raw materials get measured or weighed into clean, labelled containers, with tolerances defined where exact quantities cannot be achieved. In-process controls and their acceptance criteria need defining in a specification and performing at defined frequencies, with out-of-criteria results reported and investigated.
The same documentation, pre-start check, and in-process control logic applies to filling and packaging, with its own specific additions. A traceability code gets assigned to each unit of finished product, linked back to production records. The packaging line itself needs identifying alongside the finished product name and traceability code at all times. On-line control equipment, where used, needs regular checking against a defined programme with records maintained.
Filling and labelling are usually continuous; where they are not, segregation and identification measures need applying to prevent mix-ups or mislabelling. COS-GMP adds a specific requirement not stated as explicitly in ISO 22716: packaging lines need sufficient clearance from other packaging lines so that line clearance activity is not voided and no risk is created to the stock item — directly addressing the practical risk of cross-contamination between adjacent lines running simultaneously.
The most common gap is the line clearance and packaging line separation requirement, particularly in facilities running multiple packaging lines close together. A line clearance check performed correctly on one line can still be undermined if an adjacent line is positioned closely enough that material, dust, or components could plausibly cross between them.
The second common gap mirrors ISO 22716 closely — work-in-process handling during an interrupted continuous run, where segregation and identification get applied inconsistently under time pressure to restart production quickly.
Production control software that generates traceability codes automatically and links them through works orders removes much of the manual record-keeping burden this section describes. In-process control failures need to connect to nonconformance management so that out-of-criteria results are tracked and investigated formally rather than handled informally on the production floor.
This post is part of the Cornerstone COS-GMP series. See the full series summary with links to all 11 sections.
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