CGMP official partner: CE.way Regulatory Consultants Limited
CE.way Regulatory Consultants Limited is a provider of EU Responsible person services and other services for cosmetic companies. Visit their website to find out more: www.ceway.eu
CGMP WEBSITE PURPOSE
Cosmetic companies that want to sell their products on the EU market have to produce these products according to the GMP standards. Compliance with GMP standards can be demonstrated by obtaining ISO 22716:2007 certificate.
In line with our policy to help cosmetic manufacturers become aware of the relevant regulatory requirements that they have to follow, and to make it easier for them to be compliant with them, we compiled a list of companies that provide either training on GMP ISO 22716 standards, perform certification audits, issue GMP ISO 22716 certificates, or all of the above.
This is by no means a definite list of companies that help cosmetic manufacturers obtain an ISO 22716 certificate. CMGP Cosmetic Good Manufacturing Practice website also can’t make any guarantees regarding the quality or current availability of their services, and we do not intend to promote the services of any individuals or companies listed.
Therefore we kindly invite companies offering any services in regards to ISO 22716 good manufacturing practice standard who are not currently included in this list to send us an email, and we are going to include them in the list.
In line with our policy to help cosmetic manufacturers become aware of the relevant regulatory requirements that they have to follow, and to make it easier for them to be compliant with them, we compiled a list of companies that provide either training on GMP ISO 22716 standards, perform certification audits, issue GMP ISO 22716 certificates, or all of the above.
This is by no means a definite list of companies that help cosmetic manufacturers obtain an ISO 22716 certificate. CMGP Cosmetic Good Manufacturing Practice website also can’t make any guarantees regarding the quality or current availability of their services, and we do not intend to promote the services of any individuals or companies listed.
Therefore we kindly invite companies offering any services in regards to ISO 22716 good manufacturing practice standard who are not currently included in this list to send us an email, and we are going to include them in the list.
ISO 22716:2007 AND THE EU COSMETICS REGULATION 1223/2009
Cosmetics Good Manufacturing Practices (GMP) is one of the pillars of the New EU Regulation for cosmetics - Regulation 1223/2009. This regulation sets very high requirements to ensure consumers’ safety. Amongst these new legal requirements, all cosmetics products placed on the EU market will have to be produced according to the GMP standards described by ISO 22716.
Good manufacturing practice is a part of the quality assurance which ensures that the products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
Article 8 in the EU cosmetics Regulation is dedicated to the good manufacturing practice:
1. The manufacture of cosmetic products shall comply with good manufacturing practice with a view to ensuring the objectives of Article 1.
2. Compliance with good manufacturing practice shall be presumed where the manufacture is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union.
ISO 22716 is an international standard that gives guidance for the production, control, storage, procedure documentation and shipment of cosmetic products. The guidelines cover the quality and safety of the product. They do not, however, cover safety aspects for the personnel engaged in the plant, or the protection of the environment. The guidelines in ISO 22716 are not applicable to research and development activities and distribution of finished products.
ISO 22716 provides guidance and requirements in the following areas:
- Personnel
- Premises
- Equipment
- Raw materials and packaging materials
- Production
- Finished products
- Quality control laboratory
- Treatment of product that is out of specification
- Wastes
- Subcontracting
- Deviations
- Complaints and recalls
- Change control
- Internal audit
- Documentation
Full ISO 22716 text can be obtained (among others) through the ISO certification website:
http://www.iso.org/iso/catalogue_detail?csnumber=36437
Good manufacturing practice is a part of the quality assurance which ensures that the products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
Article 8 in the EU cosmetics Regulation is dedicated to the good manufacturing practice:
1. The manufacture of cosmetic products shall comply with good manufacturing practice with a view to ensuring the objectives of Article 1.
2. Compliance with good manufacturing practice shall be presumed where the manufacture is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union.
ISO 22716 is an international standard that gives guidance for the production, control, storage, procedure documentation and shipment of cosmetic products. The guidelines cover the quality and safety of the product. They do not, however, cover safety aspects for the personnel engaged in the plant, or the protection of the environment. The guidelines in ISO 22716 are not applicable to research and development activities and distribution of finished products.
ISO 22716 provides guidance and requirements in the following areas:
- Personnel
- Premises
- Equipment
- Raw materials and packaging materials
- Production
- Finished products
- Quality control laboratory
- Treatment of product that is out of specification
- Wastes
- Subcontracting
- Deviations
- Complaints and recalls
- Change control
- Internal audit
- Documentation
Full ISO 22716 text can be obtained (among others) through the ISO certification website:
http://www.iso.org/iso/catalogue_detail?csnumber=36437