In September 2017, the European Federation for Cosmetic Ingredients (EFfCI) published a revised version of its GMP certification scheme for cosmetic ingredients. In this article, we will take you through the main changes to the standard, in order to help you prepare for your next certification audit.
Since the initial publication of the EFfCI certification scheme in 2005, the standard has gone through 4 revision phases. The main reason for the current revision has been the publication of ISO 9001:2015, on which the EFfCI scheme builds. Although the harmonization of the EFfCI GMP standard with the new version of ISO 9001 introduces a couple of changes, we do not expect sites to encounter any problems when transitioning to the new version.
Organizations that are currently certified to the 2012 edition of EFfCI GMP will need to align their quality management system to the 2017 edition of the EFfCI GMP standard and seek certification to it. Organizations have until the end of 2018 to complete the transition. From the 1st January 2019 only a certificate to EFfCI GMP: 2017 will be considered valid.
The transition to the 2017 edition can be achieved in a surveillance or a recertification audit.
- In line with ISO 9001:2015, the new standard emphasizes the context in which the quality system operates as well as the involvement of interested parties. For manufacturers of cosmetic ingredients, the context and interested parties perfectly align with the concepts of GMP and the protection of consumer safety
- An independent quality unit is required in the new edition
- The readability of the standard has been approved by integrating guidance and the standard, instead of having the standard as an annex
- More emphasis that the organization must have the resources to effectively implement the GMP requirements
- If quality critical activities are outsourced, these need to comply with the cosmetic ingredient GMPs
- Any special storage conditions must be communicated on the product label
- The standard now includes a definition of „significant change“ to support communication
- The standard requires organizations to define the retention period of retain samples
- The scheme can now also be used by distributors of cosmetic ingredients. Appendix F enables distributors to identify which parts of GMP do not apply to them, so that they can implement the remaining principles
- The scheme now includes rules for multi-site certification