A clear and transparent set of Good Manufacturing Practices is a legal requirement under European regulation EC 1223/2009 for any manufacturer of cosmetic products looking to release their products onto the European Market. Installed in order to ensure harmonization with consumer health and safety requirements inside the European Union, Regulation 1223/2009, in connection with ISO 22716:2007, lays out a number of guidelines all manufactures must adhere to. Factors falling into the Good Manufacturing Practices (GMP) process can include things like product control, shipment, and storage, as well as proper waste management and recall procedures – many of which are included in a cosmetic product’s Product Information File (PIF).
In many cases this can often cause undue stress for manufacturers who find themselves asking whenthey should begin the compliance process and how they can prove their compliance once the process is completed, sometimes questioning through lack of regulatory knowledge whether, if at all, their product is in line with ISO guidelines. It may relieve some to hear that while compliance with and proof of GMP is mandatory, there are several ways that evidence can be provided, and while compliance with ISO guidelines may be the most straightforward way, there are other options.
As stated above, evidence of Good Manufacturing processes can be provided in a number of ways including self-declaration as a manufacturer, or by having a third-party issue a certificate following an on-site audit. A number of the following factors must be taken into consideration in the proof of GMP:
- Manufacturer’s staff
- Premises
- Equipment
- Raw Materials
- Manufacturing Process
- Waste Management
- Change Management
- Complains and Recalls
- Auditing and Quality Control
- Documentation
- Storage
This is only a brief outline of some of the factors covered under GMP, others include guidelines for subcontracting, treatment of product deviations, control of the finished product, and more. As is the case with many European cosmetic regulations, adherence and proof of GMP within Europe is presumed, and the onus to be compliant is entirely on the manufacturer.
For more information on how to implement best GMP, to get a quote on our Responsible Person or advisory Services, or to get in touch with our team of European legislative experts, contact us today!