Cosmetic products must be manufactured in accordance with Good Manufacturing Practice, and ISO 22716 provides a practical framework for documenting and maintaining it.
Scope of ISO 22716
The guidelines cover personnel, premises, equipment, raw and packaging materials, production, finished products, quality control, deviations, waste, subcontracting, complaints, recalls and documentation.
The system should be proportionate to the organisation and product types. A smaller site may have shorter documentation, but core controls, responsibilities and traceability still need to be clear.
Documentation must describe actual practice
Procedures and records should reflect what genuinely happens. Generic templates that are disconnected from equipment, premises, personnel and processes do not provide reliable control.
Every form should have a purpose, owner and retention rule. Missing or reconstructed records weaken evidence that a batch was manufactured under controlled conditions.
Practical checkpoint
Every conclusion should be linked to the exact formula, document and market-material version. This makes it possible to demonstrate which evidence supported the regulatory decision.
Gap assessment and implementation plan
An initial gap assessment compares the existing system with relevant parts of the standard, ranks gaps by risk and assigns owners, deadlines and evidence for completion.
Priority usually goes to risks that may directly affect product identity, quality or microbiological safety, followed by traceability, batch release and management of non-conforming products.
Deviations, changes and CAPA
A deviation should be recorded, its effect on product assessed and an immediate correction defined. Recurrent or significant problems require root-cause analysis and corrective and preventive action.
Supplier, equipment, process, formula or packaging changes should undergo controlled assessment before implementation. This connects GMP controls with the PIF and safety assessment.
Audits and continual improvement
Internal audits verify whether the system operates in practice and whether actions are effective. Each finding should have an owner, deadline and closure evidence.
Trends in deviations, quality-control results, complaints, returns and supplier changes support management review and prioritised improvement.
Frequently asked questions
Is ISO 22716 certification mandatory?
Not necessarily, but manufacture in compliance with Good Manufacturing Practice is mandatory.
Can the system be adapted for a small manufacturer?
Yes. It should be proportionate to processes and risks while maintaining appropriate control and traceability.
Are generic SOP templates sufficient?
No. They must be adapted to the organisation’s actual processes, equipment, responsibilities and records.
Official sources and further reading
- European Commission — Harmonised standard EN ISO 22716:2007
- Regulation (EC) No 1223/2009 on cosmetic products
This article is for general information and does not replace an assessment of the specific product, formula and supply chain. Legislation and guidance may change after publication.