GMP & ISO certifications
Our company is following Good Manufacturing Practices (GMP) and the official ISO 22716-2007 standard since many years, and was officially certified in 2019.
What is Good Manufacturing Practice (GMP)?
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to defined quality standards. It is designed to minimize the risks involved in any production that cannot be eliminated through testing the final product. Our objective is to ensure our products are safe and of the highest quality.
GMP covers all aspects of production from the starting materials (seeds, plants, soil etc.), premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.
Good Manufacturing Practices (GMP) is mandatory for cosmetics
Surprising to many, Good Manufacturing Practices (GMP) of cosmetic products are mandatory in the EU, and are highly recommended by many other countries, such as the United States.
The Cosmetics Regulation (EC) 1223/2009 requires that all cosmetic products placed on the European market comply with Good Manufacturing Practices (GMP) set by the ISO 22716 standard.
The Regulation requires us to add a declaration of compliance associated to the manufacturing facility to the Product Information File (PIF).
What is the ISO 22716 standard?
The ISO 22716 standard defines the quality and reproducibility of cosmetic products found on the European market. The products must be GMP and Regulation 1223/2009 compliant.
Our standard includes:
- Raw materials and packaging items
- Finished products
- Internal and external testing
- Treatment of off-specification and deviations
- Waste and by-products
- Subcontracting etc.
- Complaints and recalls.
- Change management
- Internal audit
- Quality service
Auditor & timeline
Our implementation process of the GMP and ISO 22716-2007 standard started in the beginning of 2019 and was completed by SBD in January 2020.
Our implemented of the standard is officially notarised in Zug, Switzerland.