Best practices in hygiene and organisation
A market approval process
To respond to mistrust in the nineties induced through several sanitary and food crises, a number of pharmaceutical industry players have put in place a certification process called GMP, now guaranteed through an international organisation.
Any player benefiting from an authorization to produce has to do so respecting the usage in conformity with the specifications quoted in the market approval. Under no circumstances can they expose a patient to a risk in terms of security, quality or efficiency of the product.
GMP are targeted to limit risks in two areas:
– cross contamination (with another product or an internal or external contamination agent);
– labelling and ingredients (identification leading to misinterpretation).
They insist on best practices in hygiene and organisation having to be in place at all levels.
The French ANSM (National Agency for Drug Safety) no longer communicates on paper since april 15th since granted certificates are now available in the community database EudraGMDP, following article 111(6) of directive 2001/83/CE modified (http://eudragmp.ema.europa.eu).