3 minute read
COS-GMP
By Robert Low, Lead Management System Specialist
COS-GMP is Apex Global Quality’s cosmetics Good Manufacturing Practices standard, built as a clause-based re-imagining of ISO 22716. It was developed with a clear set of objectives stated directly in its Purpose section: enhancing clarity, eliminating redundant text, addressing commonly misinterpreted aspects of the older standard, integrating risk management and senior management commitment more explicitly, refining the section structure, ensuring applicability to outsourced and subcontracted services, simplifying internal and external auditing, and broadening scope to cover product categories ISO 22716 excludes — pet care being the clearest example.
The standard’s References section points to its underlying influences directly: ISO 22716:2007, ISO 22715:2006 on labelling, BRCGS Consumer Products Issue 4, the Codex Alimentarius Commission’s HACCP guidelines, FDA cosmetics GMP guidance, and China’s GMP standard. COS-GMP also introduces a colour-coded system for evidential requirements throughout — green for documents, blue for records, orange for specifications, red for risk assessments, and purple for trending — and refers to what many organisations call their quality department as “Technical Compliance” throughout, reflecting the standard’s view that quality is everyone’s responsibility, not one department’s alone.
From there, the standard moves through eleven substantive sections. We have published a detailed explanation of each, working through what the standard actually requires, where manufacturers most commonly fall short, and how each section connects to the others.
1. Documentation — document and record control, including detailed electronic documentation validation requirements
2. Risk Control — the formal HARA methodology, Critical and Quality Control Points, chemical, foreign body, and glass and brittle material controls
3. GMP Safety and Quality Management — nonconformances, CAPA, concessions, traceability, complaints, recalls, procurement, subcontracting, change control, and internal audits
4. Personnel — organisation, the documented GMP policy, competence and training, and hygiene and health
5. Premises and Site Standards — the documented site plan, control zones, flow, infrastructure, staff facilities, and waste
6. Equipment — design, new equipment acceptance, calibration, cleaning, and maintenance
7. Purchasing and Goods Intake — receipt, identification, release, and water as a stock item
8. Production — bulk manufacturing and filling and packaging operations, using traceability codes throughout
9. Storage and Despatch — FEFO stock rotation, positive release, despatch, and returns
10. Inspections and Acceptance — test methods, acceptance criteria, sampling, and retain samples
11. Design and Development — formulation records, stability and compatibility testing, labelling, and the legality of marketing claims
Reading across all eleven sections, the expansion areas are consistent with what the standard’s own Purpose section promises. Risk control is far more structured, with a named HARA methodology and explicit Control Point categories. Electronic documentation gets genuinely detailed validation requirements suited to modern digital systems rather than paper-era assumptions. Design and development, along with labelling and claims legality, is covered in real depth — ground ISO 22716 leaves to other standards entirely. And throughout, the standard is more explicit about senior management’s documented, communicated commitment, rather than leaving that commitment implicit.
For manufacturers already familiar with ISO 22716, COS-GMP will feel recognisable in structure but noticeably more prescriptive in several specific areas — which is, by its own stated design, exactly the point.
If you are working toward COS-GMP or ISO 22716 alignment, our GMP consultation services are delivered by practitioners with direct cosmetics audit experience across both standards.
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