News \ Legislaltion - N°64 GMP, un atout pour l’export an asset for export The Facophar Santé association,which is a founder and managingdirector of the French FederationTÉMOIGNAGE / TESTIMONY of Healthcare Industries alongside LEEM, aims amongst others, to support the Spécialisés dans la fabrication de compléments national and international development of alimentaires (gélules de micro-granules, gélules de the French companies operating in the area poudre, capsules molles…) les laboratoires Activa ont of natural substances for pharmaceutical, récemment intégré le programme élaboré par Facophar cosmetics and dietetic use - including food Santé. Le pré-audit s’est déroulé début 2018 sur le site supplements. de Carros. Cette étape préalable indispensable a permis The objective of Facophar Santé is to à l’entreprise de bénéfi cier des conseils d’un consultant promote these “French Excellence” com- expert avec qui elle a pu établir et valider un plan d’actions précis actuellement en cours de déploiement. panies on markets with strong growth Au cours du pré-audit, des besoins en formation du potential, where their products are in high personnel ont été identifi és, auxquels Facophar Santé demand: North and South America, the est en mesure de répondre: quatre modules de Middle East, Asia... formation aux exigences des GMP FDA CFR 21 partie If the “French Quality” is rewarding for 111 sont ainsi proposés aux entreprises qui souhaitent every company with export ambitions, aborder sereinement l’audit de conformité. Cet audit est the certificate of compliance with FDA’s réalisé, au choix de l’entreprise, par Intertek ou DNV-GL, GMP CFR 21 issued by Facophar Santé deux organismes internationaux reconnus et accrédités 079 is a mandatory commercial requirement in COFRAC sélectionnés pour l’occasion par Facophar these markets. Santé. Within this context, Facophar Santé has developed a pre-auditing, staff training (that Specialized in the manufacture of food supplements may be included in a company’s training (capsules containing micro-granules or powder, soft budget) and independent auditing program gels...) Activa Laboratories have recently signed up to with an audit committee in charge of cer- the program developed by Facophar Santé. The pre- tifying or not, in light of the audits, the com- audit meeting took place at the beginning of 2018 at the laboratory’s unit based in Carros. This essential pany’s compliance with the requirements of preliminary step allowed the company to receive the FDA GMP CFR 21 Part 111. The audit recommendations from an expert consultant, with committee is the one that will also validate whom it was able to establish and validate a specifi c the signing of the Letter of Compliance. action plan, which is currently being implemented. Implementation and successful compliance Staff training needs were identifi ed during this pre- with the requirements of the FDA GMP CFR audit meeting and Facophar Santé proposes specifi c 21 Part 111 as a result of the pre-audit solutions to meet these needs, such as four training session, rests with the business operator. modules to the requirements of the FDA GMP CFR 21 While such an approach necessarily has a part 111 for the companies that want to approach the cost, the incurred expenses are a very small compliance audit with confi dence. Depending on the investment as compared to the poten- choice of the company, the audit is to be carried out by Intertek or DNV-GL, two international organizations tial leverage and the added value for the recognized and accredited by COFRAC and specifi cally company, staff and products. selected for this purpose by Facophar Santé. Indeed, compliance with the FDA GMP ine- vitably secures all the production stages and the involved staff: production, produc- Source: Facophar tivity and quality gains that contribute to the international success of the company and the recognition of its “excellence”.■ News on Functional & Health Ingredients \ N°64 \ July - August - September 2018 \ ■