Goals
The objectives of the prestation Evaluation of Good manufacturing practices: Pharmaceuticals :
Conduct an assessment of the Good Manufacturing Practices (and quality system) of establishments that aim to manufacture pharmaceutical products but have not yet received approval from the ANSM (National Agency for the Safety of Medicines and Health Products), and who therefore struggle to develop contracts with pharmaceutical companies.
Who is Pharmaceutical GMP for?
Agri-food or cosmetic companies that manufacture an ingredient and want to expand into the pharmaceutical sector.
Modalities
The ANSM, by a decision dated December 4, 2013 (Official Journal of the French Republic of January 7, 2014, text no. 2 of 82), has developed a new edition of the Good Manufacturing Practices (GMP) guide, which was published in the Special Official Bulletin of the Ministry of Social Affairs and Health under no. 2014/1 bis.
This guide was developed following the European model of the Good Manufacturing Practice guide for medicinal products for human and veterinary use.
Deliverables
Detailed report submitted at the end of the service, and evaluation certificate if the conditions are met.
Who is Pharmaceutical GMP for?
Agri-food or cosmetic companies that manufacture an ingredient and want to expand into the pharmaceutical sector.
Modalities
The ANSM, by a decision dated December 4, 2013 (Official Journal of the French Republic of January 7, 2014, text no. 2 of 82), has developed a new edition of the Good Manufacturing Practices (GMP) guide, which was published in the Special Official Bulletin of the Ministry of Social Affairs and Health under no. 2014/1 bis.
This guide was developed following the European model of the Good Manufacturing Practice guide for medicinal products for human and veterinary use.
Deliverables
Detailed report submitted at the end of the service, and evaluation certificate if the conditions are met.
Description
Have your establishment's good manufacturing practices in the pharmaceutical sector recognized.
This service does not replace the marketing authorization and Good Manufacturing Practice certificate, which can only be issued by the ANSM following its inspections and prior to any production of pharmaceutical substances.
Third-party evaluation carried out, according to the certification bodies' own procedures, of the manufacture, packaging, storage (excluding transport), quality control, purchasing, sales, Quality Department and related services (cleaning, maintenance, etc.).
The evaluation certifies that an independent entity has assessed conformity, which provides guarantees to a potential future customer.
Steps and process
1. Certification request
2. Planning
3. Initial audit
4. Certification decision
5. Certificate issuance
6. Annual follow-up audit
This service does not replace the marketing authorization and Good Manufacturing Practice certificate, which can only be issued by the ANSM following its inspections and prior to any production of pharmaceutical substances.
Third-party evaluation carried out, according to the certification bodies' own procedures, of the manufacture, packaging, storage (excluding transport), quality control, purchasing, sales, Quality Department and related services (cleaning, maintenance, etc.).
The evaluation certifies that an independent entity has assessed conformity, which provides guarantees to a potential future customer.
Steps and process
1. Certification request
2. Planning
3. Initial audit
4. Certification decision
5. Certificate issuance
6. Annual follow-up audit
Periodicity
This audit is a one-off, as it is intended to enable an industrialist to reassure potential future customers.
However, an application for official approval must then be submitted to the ANSM (French National Agency for Medicines and Health Products Safety) before any production and sale of pharmaceutical products, which will formally authorise the site to produce medicines or medicinal substances.
Only the ANSM is authorised to approve pharmaceutical sites.
However, an application for official approval must then be submitted to the ANSM (French National Agency for Medicines and Health Products Safety) before any production and sale of pharmaceutical products, which will formally authorise the site to produce medicines or medicinal substances.
Only the ANSM is authorised to approve pharmaceutical sites.
Prestation
Evaluation of Good manufacturing practices: Pharmaceuticals
Ref : TSYS0140