What are the big differences between GMP and ISO 22716?

Drugs have the Good Manufacturing Practices (hereinafter referred to as GMP), cosmetics have the ISO 22716 standard. If the need to secure the production of drugs is not to prove, it is not always obvious for cosmetic products. Indeed these “substances or mixtures intended to be put in contact with the superficial parts of the human body” (extract article 2, cosmetic regulation and article L.5131-1 of the CSP) can be dangerous if their production is not controlled at least. The ISO 22716 standard is intended to be THE reference for the industrials of the market. But what are the big differences between GMP and ISO 22716?

ISO 22716

ISO 22716 gives practical advice

Certainly the number of pages constituting each document is already a big difference (more than 300 pages in total for the GMP, counting the Annexes and the GMP for the active substances against less than fifty for the 22716 …) but we will not go on this ground for this article.

The choice of words represents one of the major differences. When reading the ISO 22716 standard, what draws attention, for the industrial pharmacist I am, it is the choice of the expression “it is proper to” for any given directive, where the GMPs use the expression “it is due to “. The expression “it is proper to”: to be appropriate to something or to be in perfect conformity with something seems to leave room for more flexibility than the expression “it is due to”: to be held or obliged to do something. However, whoever chooses to follow one or the other will choose to comply with one or the other. So if the expression used does not have the same power at first glance, the purpose is the same.

The second difference lies in the topics covered by the ISO 22716 standard. If the main chapters of the GMP of medicines for human use, such as resources, premises, manufacturing or complaints and recalls, are included in ISO 22716 they are nevertheless much less detailed. What is not included in the ISO 22716 standard are the annexes such as the one dealing with qualification and validation. ICH Q9 for quality risk management is also not included.

Finally the few points mentioned above still show great similarities between the 2 documents. GMPs for medicines for human use give the impression of being “the old sister” of the ISO 22716 standard and that the latter tend to copy on it. This evolution will not necessarily satisfy all the professionals of the cosmetic field but what is more natural than to have the same requirements for the drugs than for the products we apply on our skin or on the one of our children?

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