Evidence of compliance with Good Manufacturing Practice

Evidence on Good Manufacturing Practices (GMP) is one of the essential elements when building up the Product Information File of a Cosmetic product. The Good Manufacturing Practices were created in order is to ensure that the manufacturing method is in alignment with the health requirements.

The GMP is only in reference to the entity which actually produces the product (the Producer). However, any entity placing cosmetic products onto the EU market under its name is required to have evidence of GMP (in reference to its different Producers) as part of their Product Information File (PIF).

Evidence on Good Manufacturing Practices (GMP) can be obtained through:

  ✓   A signed declaration by the Producer(s)
  ✓   A third-party certificate in reference to an on-site audit

Either method must indicate the chosen criteria of the Good Manufacturing Practices. There are different criteria which can be adopted in case of Good Manufacturing Practices:

  ✓   Colipa Cosmetic Good Manufacturing Practices
  ✓   Council of Europe: Guidelines for good manufacturing practice of cosmetic products
  ✓   CEN/ISO norm 22716

European regulation directs that the CEN/ISO Norm 22716 serves as presumption of conformity towards GMP. As such, a simple way to ensure that producers provide sufficient evidence is through the ISO 22716 standard which was adopted as a CEN standard (a European Standard).

To find out more about the Good Manufacturing Practices, Contact Us. 

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