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Nurturing the relationship between industry and regulators  


To read the full article in PharmaTech click here.

PA life sciences expert David Lerner weighs in on how pharma companies can best prepare for a regulatory inspection.

According to David: “There are a variety of things pharma companies can do when preparing for a regulatory inspection, including having good controls, processes, training, and systems up front. There is simply less preparation effort if the company is in a good compliance state.” 

David added: Companies should also identify and address risks prior to inspections.  Knowing your risks allows you to better prepare for inspection questions.  You also need to be seen as addressing the risks that you have found.

Further, David said: Addressing findings from previous inspections is also imperative. Inspectors review previous inspection reports and expect that prior commitments have been completed.  Most importantly, any documents the inspectors ask for should be provided in a timely manner.

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David went on to say: Companies may benefit from providing inspectors with an overview of their facilities and processes. Recognize that the inspector is dropping into your environment with little context. By providing them with the context they will be better able to understand what you do and ask better questions.  Storyboards are useful because they help the inspector understand the situation rather than forcing the inspector to pull information from one or more documents.

David states: While preparation may be key, there are obvious things companies should avoid doing during an inspection, such as lying, being evasive, or arguing with inspectors. The inspector will want direct answers to direct questions and to talk to the people doing the job, not management.

David continues: Companies should take FDA 483 observations seriously, but be careful not to overcommit. When the inspector returns, they expect the commitments to be completed and could escalate actions if not completed.

David concludes: Addressing root causes of observed violations is key.  The agency really wants to see that you are addressing the root cause and that you are addressing this issue across the organization. As an example, if the inspector found that a particular non-conformance (NCR) was not investigated fully, it is equally important to both to explain what happened in that instance (and why you made specific decisions) and what you are doing to prevent future insufficient NCR investigations.

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