The trend is evident. The number of serious GMP deviations identified during inspections is growing. This also shows in the analysis of FDA warning letters. In Europe, too, serious GMP deviations lead more and more often to consequences. The EDQM has e. g. withdrawn the Certification of Suitability (CEP) from a whole series of firms after GMP inspections. 

But what is the reason for this? Have the firms really become "worse"? A look behind the data reveals the solution. Three important parameters have changed.

Firstly: The number of inspections has clearly gone up. The FDA has e. g. noticeably increased the number of inspectors. Joint inspections, like the current pilot by FDA, EMA and TGA, contribute considerably to the higher number of inspected sites.

Secondly: Risk-based inspection plans, which are established in almost all authorities nowadays, have resulted in inspections of many firms that were hardly or not at all supervised formerly, e. g. because they were far out. With active ingredients manufacturers in Asia leading the way.

Thirdly: Serious deficiencies are sanctioned more consistently. In the past, the FDA realised e. g. that there were cases in which further follow-up measures were not taken even after the issuance of a warning letter. In this context, a quote by an FDA official became famous who commented the lax handling of warning letters with the words: "We no longer intend to just send them like we send Christmas cards." In Europe, too, action is taken more and more consistently. Quite recently e. g. through a recall of all batches of a medicinal products decreed by the EMA (formerly EMEA) due to GMP problems at an API manufacturer. The withdrawal of CEPs also leads to prompt consequences, not only for the API manufacturer, but also for the firms using the active pharmaceutical ingredients for their finished medicinal products.

The further development is predetermined. Both the FDA and the EU have concrete plans for making pharmaceutical manufacturers responsible for the entire supply chain. Without a comprehensive and well-functioning system for controlling the supply chain, which is complex in many companies, the number of complaints in inspections will increase further.

Author:
Oliver Schmidt
On behalf of the European Compliance Academy (ECA)

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