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Industrial Standards Held

Certified Laboratory • ANSM health authority (formerly known as AFSSAPS), authorization M15/219
• ANSES (ANMV) N° V 0100/96
• All dry forms in Development, Production and Clinical trials and biologics, immuno-biologics products
• Audit DDPP/DIRECCTE/DGCCRF for nutraceutical and cosmetic markets

Industrial standards held

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Bonnes Pratiques de Fabrication (BPF) French equivalent of Good Manufacturing Practices (GMP) : practices required in order to conform to the guidelines recommended by ANSM Healt Autority that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

ICH Guidelines edited by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). o Q9 « Quality Risk Management»
Define how principles of risk management can be more effectively applied and consistently integrated into decisions, both by regulators and industry, regarding the quality of pharmaceuticals across the product lifecycle, including GMP compliance.

o ICH Q10 « Pharmaceutical Quality Systems»
Establish and maintain a state of control that can ensure the realisation of a quality drug product and facilitate continual improvement over the life cycle of a drug product

HACCP : Hazard Analysis Critical Control Point

ISO 9001 - ISO 22000

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