At the 12th congress in Chartres, after presenting an overview of their most recent cosmetics regulatory inspections, ANSM agents Thierry Thomas and Vanessa Picot addressed good manufacturing practice inspections. Their observations were confirmed again and again: there is still a lot of work to be done to comply with the requirements of the Cosmetics Regulation!
Market monitoring inspection division head Thierry Thomas and Cosmetic products inspector Vanessa Picot started off with these statements: ‘GMP inspections continue to cause a lot of instances of noncompliance. They are, however, crucial in ensuring the quality of the products manufactured, in ensuring traceability, and in preventing the various risks inherent in manufacturing.’
Since Cosmetics Regulation 1223/2009 entered into force, ISO 22716 has been the standard of reference. But most manufacturers still find it rather difficult to adhere to. On average, inspectors from ANSM (France’s drug and health product safety agency) find 38 instances of noncompliance per inspection report:
• 4% are considered critical, meaning they constitute ‘a failure that directly impacts the quality of the cosmetic product and may threaten consumer health and safety or have an immediate result on public health’.
• 25% are major and constitute ‘a failure that seriously impacts the organization of the establishment inspected and may have an indirect effect on the quality of the cosmetic product or have a deferred result on public health’.
• 71% are minor.
As in years past at the same congress, the ANSM agents provided the long list of instances of recurrent noncompliance with GMPs. …
