3 minute read
ISO 22716
By Robert Low, Lead Management System Specialist
ISO 22716:2007 is the international standard for Good Manufacturing Practices in cosmetics. If you manufacture, pack, or hold cosmetic products, this is very likely the framework your auditor is working from, whether you are pursuing formal certification or simply aligning your operation with recognised GMP practice.
The standard opens with two sections that are worth understanding even though they do not contain operational requirements in the way the rest of the document does. Scope clarifies that the standard covers production, control, storage, and shipment of cosmetic products — it does not cover personnel safety or environmental protection, which remain governed by local legislation, and it does not apply to research and development or distribution of finished products. Terms and definitions sets out the vocabulary the rest of the standard relies on — batch, bulk product, in-process control, quality assurance, and so on — precise definitions that matter when interpreting exactly what each later clause is asking for.
From there, the standard moves through fifteen substantive sections covering the full lifecycle of cosmetics manufacturing. 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. Personnel — organisation, training, hygiene, and health requirements for everyone working in GMP-covered areas
2. Premises — facility layout, flow, construction standards, cleaning, and pest control
3. Equipment — design, installation, calibration, cleaning, and maintenance of production and laboratory equipment
4. Raw Materials & Packaging Materials — purchasing, receipt, identification, release, storage, and re-evaluation
5. Production — Manufacturing Operations — documentation, start-up checks, batch identification, and in-process control for bulk manufacturing
6. Production — Packaging Operations — filling, labelling, line identification, and work-in-process handling
7. Finished Products — release, storage, shipment, and returns
8. Quality Control Laboratory — Methods & Sampling — test methods, acceptance criteria, sampling, and retain samples
9. Quality Control Laboratory — Out-of-Specification Results — review, investigation, and the rules around re-testing
10. Treatment of Out-of-Specification Product — rejection, destruction, and reprocessing decisions
11. Wastes — classification, flow, and disposal of waste materials
12. Subcontracting — obligations of contract givers and contract acceptors
13. Deviations & Change Control — the distinction between temporary departures and permanent process changes
14. Complaints & Recalls — investigation, trending, and recall coordination
15. Internal Audit — independence, findings, and follow-up
16. Documentation — the controlled document and record system underpinning every other section
Read across all sixteen sections, a consistent pattern emerges. ISO 22716 does not generally ask manufacturers to do anything exotic — it asks for defined processes, evidence those processes were actually followed, and a clear chain of authority for decisions that affect product quality. The manufacturers who struggle at audit are rarely the ones with a fundamentally different process. They are the ones where the gap between the documented process and daily reality has grown without anyone noticing — exactly the kind of drift a connected QMS platform is designed to catch before an auditor does.
If you are working toward ISO 22716 certification or preparing for a surveillance audit, our ISO 22716 consultation service is delivered by practitioners with hands-on cosmetics GMP audit experience — not a generic consultancy applying a template.
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