ISO 22716 addresses good practices for production, control, storage and shipment. GMP assessment is not a product approval that independently verifies all safety and efficacy claims.
No. Assessment of manufacturing practices differs from assessment of a specific formula's safety. EU cosmetics legislation treats GMP and product safety documentation as separate duties. Complete evidence for the relevant formulation, use and claims. A facility certificate does not automatically approve every product.
Assess the deviation's product effects and necessary controls. The test list may not detect every process problem. Authorised release should consider production, testing and deviation records together. Favourable results do not automatically resolve unexplained incorrect weighing or mixing events.
Define duties for bulk acceptance, storage, filling, packaging and batch identity. Agree acceptance criteria and deviation communication. Suitable bulk product does not automatically control incorrect packaging or filling conditions. Arrange record access for the brand and service provider.
Assess new packaging identity, acceptance conditions and compatibility with the product. Determine stability or interaction studies according to risk. Match production and inspection instructions to the new version. Identical volume and appearance do not alone establish equivalent material or closure performance.
Check ISO 22716's production scope and its boundaries concerning research and development. Explain the purpose of any pilot manufacturing. A cosmetic research activity is not automatically within scope merely because of its name. Identify the customer's required evidence and other applicable requirements separately.
Equipment, staff, hygiene, manufacturing and control practices must be ready. Written documents alone do not establish operating evidence. Reassess transferred processes in the new conditions. Allow trials, checks and corrections without assuming that the old certificate automatically covers the new address.
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