Cosmetics Good Manufacturing Practices (GMP)
PharmOut have helped a number of cosmetics companies set up manufacturing facilities from scratch, i.e. from the initial designing and building of the facilities all the way to setting up document management systems, validating equipment, starting production and achieving Cosmetics GMP compliance.
For cosmetics, we work to the internationally accepted Cosmetics GMP, ISO 22716 which is used for all cosmetic products across the globe.
This standard has been effective since July 11, 2013 and has become mandatory – for example, the European Union’s new regulation, EC No. 1223/2009, has replaced the Cosmetics Directive, 76/768/EEC. This has been adopted by the USA, European Union (EU), Canada and Japan.
The EU regulatory framework goes on to state that:
“…in accordance with the relevant harmonised standards, the manufacture of cosmetic products shall comply with the principles of GMP and cosmetic products must be safe when used under normal or reasonably foreseeable conditions.
If you are building a new facility or refurbishing an old one, it’s important to have the plans independently reviewed to ensure that they meet current Cosmetics GMP requirements.
To prepare for an official regulatory audit, it’s wise to have a pre-audit performed by one our consultants to check the GMP ‘health’ of your facility. This way you can find and address any problems you might have well in advance.
If you’ve got a huge project looming in the distance and don’t know where to begin, we also offer project management services to help you get production up and running as well as complying with the relevant regulations.
If you’re short on staff or resource-poor, we can help you find temporary or permanent staff with the specific technical skills and experience that you require to move forward.
More Information on Cosmetics GMP
We find that ISO 22716, the guidelines for Cosmetics GMP, gives essential, practical, hands-on advice which is focused specifically on human, technical and administrative factors affecting product quality. The prime objective of the guidelines is to define the activities which lead to the final product corresponding to the expected specifications, and therefore product safety.
Key elements of ISO22716 include, but are not limited to:
- Quality structure, organisation and responsibilities
- Personnel and training
- Internal audit, CAPA (continuous improvement)
- Vendor assurance
- Materials management
- Laboratory testing
- Shipment / distribution
ISO 22716 sets a very high requirements to ensure users’ safety, which is that main benefit of the Cosmetics Good Manufacturing Practices as described by the ISO 22716 standard.
FDA Cosmetics GMP
This FDA guidance covers the basics of Good Manufacturing Practices for Cosmetics, and covers the following essential principles.
- Specific Guidance for Cosmetics
- Buildings and Facilities
- Raw Materials Water Color Additives Prohibited and Restricted Cosmetic Ingredients
- Laboratory Controls
- Internal Audit
- Complaints, Adverse Events, and Recalls