Cosmetics — Good Manufacturing Practices (GMP): Guidelines on Good Manufacturing Practices
The international Good Manufacturing Practices standard for cosmetics — guidelines on the production, control, storage, and shipment of cosmetic products. It is the global cosmetics-GMP baseline (referenced by the EU Cosmetics Regulation and endorsed via ICCR), and in the US it is expected to inform the mandatory GMP regulations FDA must establish under MoCRA.
Manufacturing, control, storage, and shipment of cosmetic products; addresses product quality rather than personnel safety or environmental aspects.
- 01Apply GMP across personnel, premises, equipment, and materials
- 02Control production and in-process steps with defined responsibilities
- 03Operate quality control including out-of-specification handling
- 04Maintain documentation and product traceability
Published 2007 and widely adopted; its prominence grew with the US MoCRA (2022), which directs FDA to establish mandatory cosmetic GMP expected to align with ISO 22716.
ISO 22716:2007: frequently asked questions
Quick answers to common questions about ISO 22716:2007.
What is ISO 22716:2007?
ISO 22716:2007 — Cosmetics — Good Manufacturing Practices (GMP): Guidelines on Good Manufacturing Practices — is a standard issued by the International Organization for Standardization. The international Good Manufacturing Practices standard for cosmetics — guidelines on the production, control, storage, and shipment of cosmetic products. It is the global cosmetics-GMP baseline (referenced by the EU Cosmetics Regulation and endorsed via ICCR), and in the US it is expected to inform the mandatory GMP regulations FDA must establish under MoCRA.
Who does ISO 22716:2007 apply to?
Manufacturing, control, storage, and shipment of cosmetic products; addresses product quality rather than personnel safety or environmental aspects.
What are the key requirements of ISO 22716:2007?
ISO 22716:2007 requires, among other things: Apply GMP across personnel, premises, equipment, and materials; Control production and in-process steps with defined responsibilities; Operate quality control including out-of-specification handling; Maintain documentation and product traceability.
When was ISO 22716:2007 last updated?
The current version of ISO 22716:2007 dates from November 2007. Published 2007 and widely adopted; its prominence grew with the US MoCRA (2022), which directs FDA to establish mandatory cosmetic GMP expected to align with ISO 22716.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When ISO 22716:2007 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.