Tuesday, December 26, 2017Focus

Information required in the PIF: Manufacturing method and declaration of GMP compliance

©CosmeticOBS-L'Observatoire des Cosmétiques

Article 11 of the Cosmetic Regulations precisely defines the information that must be held in the PIF. Among them: the manufacturing method and the declaration of GMP compliance.

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Under Article 11.2.c, the PIF must contain “a description of the method of manufacturing and a statement on compliance with good manufacturing practice referred to in Article 8.”

Article 8 states that:
“1. The manufacture of cosmetic products shall comply with good manufacturing practice with a view to ensuring the objectives of Article 1.
2. Compliance with good manufacturing practice shall be presumed where the manufacture is in accordance with the relevant harmonized standards, the references of which have been published in the Official Journal of the European Union.”

As a reminder, Article 1: “This Regulation establishes rules to be complied with by any cosmetic product made available on the market, in order to ensure the functioning of the internal market and a high level of protection of human health.”

In this section of the PIF, a brief overview of the method of manufacture including bulk storage and filling for the manufacturing site(s) concerned is expected. There should be a summary of the process and a cross-reference to the detailed manufacturing documentation within any specific manufacturing site.

Article 8 of the Cosmetics Regulation requires that the manufacture of cosmetic products complies with cosmetic Good Manufacturing Practice (GMP). Companies must demonstrate …

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