Formula Swiss information
GMP and ISO certifications
Our company has followed Good Manufacturing Practice (GMP) under ISO 22716:2007, the international GMP standard for cosmetics, for many years, and was certified by SBD in January 2020.
GMP makes sure our products are produced, controlled, documented and reviewed the same way, every time. It works together with the testing of every production batch.
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 minimise the risks involved in 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 starting materials such as seeds, plants, and soil, to premises, equipment, staff training, and personal hygiene.
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.
GMP is required for cosmetics in the EU
Good Manufacturing Practice for cosmetic products is a legal requirement in the EU and is recommended in many other markets, such as the United States.
The EU Cosmetics Regulation (EC) No 1223/2009 requires every cosmetic product placed on the EU market to be manufactured in compliance with GMP (Article 8). ISO 22716 is the harmonised standard for cosmetics GMP: following it is the recognised way to show that compliance.
The Regulation also requires a statement of GMP compliance in each product’s Product Information File (PIF).
What is the ISO 22716 standard?
ISO 22716 is the international standard for Good Manufacturing Practice for cosmetics. It sets out how cosmetic products are produced, controlled, stored and shipped, so that quality is consistent from batch to batch.
Our GMP system covers:
- Staff
- Premises
- Equipment
- Raw materials and packaging items
- Manufacturing
- Finished products
- Testing
- Treatment of off-specification and deviations
- Waste and by-products
- Subcontracting
- Complaints and recalls
- Change management
- Internal audit
- Quality service
- Documentation
Certification
Implementation
Our certification process for GMP under ISO 22716:2007 started at the beginning of 2019.
Certified
Our production was certified by SBD in January 2020.
Notarisation
Our implementation of the standard is officially notarised in Zug, Switzerland.