Evaluation of Good manufacturing practices: Pharmaceuticals

Who is concerned ? Company in the agri-food, cosmetics or chemical sector, that wants to work with customers in the pharmaceutical industry, or who want to develop a range of pharmaceutical products, although they are not approved by ANSM.


Follow the guidelines of the pharmaceutical industry for preserving the health of patients.


Conduct an evaluation of good manufacturing practices (and of the quality system) of establishments that aim to produce pharmaceutical products, but which have not yet received the approval of ANSM (French national agency for drugs and health product safety), and that because of this are having difficulty developing contracts with pharmaceutical firms.


Have the good manufacturing practices of your establishment in the pharmaceutical sector recognised.


The service is not a substitute for the authorisation to open and for the Good Manufacturing Practices certificate which can be issued only by ANSM after its inspections and prior to any production of a pharmaceutical substance.


The targets are agri-food or cosmetics companies that manufacture ingredients that want to develop into the pharmaceutical sector.


Third party evaluation carried out, according to the procedures that are proper to the certifying bodies, of the manufacturing, packaging, storage (outside of transport) of the quality control, purchasing, commercial, of the Quality Department and of the related departments (cleaning, maintenance, etc.). The evaluation certifies that an independent entity has judged the conformity, which provides guarantees for a possible future customer.


Standard: guide to GMP of March 2014 no. 2014/1 bis established by ANSM.


Evaluation in the form of on-site observations, examination of documents and records, interviews, that cover the requirements of the standard.


Deliverables: detailed report provided at the end of the service and evaluation certificate if the conditions are met.


 


Frequency:


This audit is occasional as it is intended to allow an industrial company to reassure its future potential customers. However an official request for approval must afterwards be filed with ANSM before any production and sale of pharmaceutical products, who will formally approve the site for producing drugs or medicinal substances. Only ANSM is authorised to approve pharmaceutical sites.


Procedures:


In a decision on 4 December 2013 (Official Journal of the French Republic of 7 January 2014, text no. 2 out of 82), ANSM developed a new edition of the guide to good manufacturing practices (GMP), which was published in the Special Official Bulletin of the Social Affairs and Health Ministry under no. 2014/1 bis. This guide was developed according to the European model of the guide to good manufacturing practices for drugs for human and veterinary use.


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