Burden of Pre-Inspection Submission Requests from Agencies Outside the US and Europe is Growing

Pharma industry experts are expressing concern with a new trend of emerging country agencies requesting significant amounts of manufacturing and facility information prior to performing GMP inspections and are proposing that the international community work toward a more clearly-defined, manageable and harmonized approach.

Primary concerns include the burden of preparing the information when what is requested has no clear boundaries or level of detail specified and does not correspond to already-prepared internal information.  Equally concerning is the potential for misinterpretation of complex information that is normally provided during an inspection when company experts are on hand to provide clarifications or answer questions that may come up.

When the documents are provided in advance, a considerable amount of time and effort is required to prepare them, and in many cases to translate them, and to ensure that they are clear and in the proper context.  In turn, time must then be spent communicating with the requesting agency to answer questions and provide follow-up information and explanations.  Firms are finding that the pre-inspection requests can be more burdensome than the inspections themselves and are diverting valuable quality resources from more productive activities.

At a conference on the “Current and Emerging EU Regulations and Inspection Trends” co-sponsored by PDA and the Irish Medicines Board (IMB) in Dublin in July, Boehringer Ingelheim (BI) Associate GMP Auditing Director Harald Scheidecker highlighted the problems that these advance document requests are creating for facilities such as his that supply internationally and suggested alternative approaches that could help avoid them.

Scheidecker’s analysis at the July conference of his firm’s experience with pre-inspection submissions complemented a related analysis that he provided on the growing burden of redundant inspections by various agencies at a 2012 workshop cosponsored by PIC/S and PDA (IPQ, May 2, 2013).

At both meetings, the BI quality official advocated the need for more international coordination and communication and for forums such as PIC/S and ICH to help find a harmonized pathway forward.

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