Monday, October 5, 2020Professional bodies

GMPs in the Covid-19 era: FDA recommendations

Les BPF en temps de Covid-19 : recommandations de la FDA

While the Covid-19 crisis has suspended FDA inspections in Europe, the US agency is nonetheless keeping an eye on the manufacturing conditions of products that are imported into its country, including drugs, OTCs (such as sunscreen, anti-perspirants, anti-dandruff products…) and biological products. In June 2020, it thus published a document of recommendations concerning GMPs (Good Manufacturing Practices) in Covid time, which was detailed during a webinar organised by IFIS on 24 September 2020.

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It was Jean-Michel Thévenin and Philippe Devès, both from IFIS (the training institute for professionals in the pharmaceutical, medical device and cosmetics industries), who presented and commented on these “Considerations for responding to Covid-19 infection in employees in drug and biological products manufacturing in terms of Good Manufacturing Practices”, which the US Food and Drug Administration (FDA) published in June 2020.

They apply, the text specifies, to human or animal active pharmaceutical ingredients, prescription drugs, over-the-counter drugs (or OTCs), and biological drug products.

“These recommendations issued by the FDA are for the moment only recommendations, but they should be be used as references during inspections,” warned the speakers at the outset. And they do not only list objectives, since the text also includes examples and solutions. It deals with three main points:
• Manufacturing controls to prevent product contamination
• Assessment of the risk of the virus in relation to product safety and quality
• The continuity of manufacturing operations, especially when employees are infected and could jeopardize ongoing production

Manufacturing controls to prevent product contamination

Manufacturers are called upon to prevent or mitigate the effects on the safety and quality of products coming from an infected or even potentially …

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