Cosmetic GMP under ISO 22716: requirements, documentation and checklist

Article 8 of the EU Cosmetics Regulation is brief: the manufacture of cosmetic products complies with good manufacturing practice in order to meet the objectives of the Regulation, above all a high level of health protection. The Regulation does not define good manufacturing practice in detail.

Instead, paragraph 2 sets a presumption: compliance with good manufacturing practice is presumed where the manufacture follows the relevant harmonised standards whose references have been published in the Official Journal of the European Union. For cosmetic products that is EN ISO 22716:2007, whose reference the Commission published in the Official Journal C 123 of 21 April 2011.

The standard is titled “Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices”. As described by the German Federal Office of Consumer Protection and Food Safety (BVL), it provides guidance on the quality-related aspects of the production, control, storage and shipment of cosmetic products.

Legally the standard is a guideline, as the German cosmetics association IKW points out. Anyone who works differently cannot rely on the presumption in Article 8 and has to demonstrate compliance with good manufacturing practice themselves. The standard is sold through the standards organisations.

Under the legal requirements, a certificate issued by a third party is not necessary; the IKW states this explicitly. Many clients and trading partners nevertheless ask for evidence, such as an audit or a self-assessment. The IKW provides a checklist for self-assessment.

What is mandatory is a description of the method of manufacturing and a statement on compliance with good manufacturing practice in the Product Information File. That duty lies with the responsible person, even when a contract manufacturer produces.

The BVL names as examples of GMP documents: exact manufacturing instructions, test descriptions for starting materials and finished products, the control and maintenance of equipment, the cleanliness and suitability of premises, and sufficient expertise of the people responsible. Comprehensive documentation of the manufacturing process that ensures traceability is particularly important.

In practice: for every batch you can trace which instruction it was made to, which raw materials were used, which parameters applied, which deviations occurred and who released the batch.

Beyond manufacturing itself, Article 7 of the Regulation requires traceability in the supply chain: at the request of a competent authority, the responsible person identifies the distributors it supplied, and distributors identify their suppliers and the distributors they supplied. The obligation applies for three years following the date on which the batch was made available to the distributor.

GMP documentation and the batch number on the label work together here. Without a clear batch, neither a complaint can be resolved nor a recall narrowed down.

GMP does not start in production. The manufacturing instruction is created in development, and every later formula change has to be carried into it. If the lab releases a new version while production still works to the old instruction, deviations are a likely result.

A chain without breaks helps: formula version, manufacturing protocol with phases and parameters, batch, test results and release are linked to one another. Then, when a question arises, it is immediately clear which version went into which batch.

Is there a written manufacturing instruction in its current version for every product? Are raw materials checked and labelled on receipt? Are premises and equipment cleaned and maintained, and is that documented? Do staff know their tasks, and are they trained?

Is every batch recorded with parameters, deviations and release? Can the raw materials used be traced to a finished batch? Is there a procedure for complaints and recalls? And does the responsible person hold a current GMP statement? The IKW checklist goes much further and is suitable for a structured self-assessment.

A system does not replace quality management, but it can carry the documentation: manufacturing protocols with phases, mixing steps, parameters and deviations, linked to the formula version and the batch, plus the test results. Whether day-to-day practice meets good manufacturing practice shows on the shop floor and in the audit.