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Our strategic software partner and leading eQMS provider - MasterControl,  recently interviewed a senior  officer at the US FDA’s Center for Drug Evaluation and Research (CDER), and was provided the following response to the question:


What are the top three things that an FDA investigator looks for during a GMP inspection and why?


“Our goal is to determine if the firm’s manufacturing operations are in a state of control. The CGMPs are a management-based regulatory approach. We do not specify how a company must structure its quality system. The regulations provide general expectations and we let the firm’s management structure its GMP compliance program accordingly. A GMP inspection will then be conducted to determine the effectiveness of a firm’s quality system. There are many ways to make this assessment; however, there are some key areas that investigators are trained to focus on.

  1. First, are the manufacturing processes validated? Can the firm show that it has good process understanding and control, and does the actual data — the testing data, the process deviations, complaints, etc. — bear that out?
  2. Second, when there are problems, and everybody has at least some problems, what is the firm’s reaction? When there’s a deviation, we look at a firm’s system of investigation — how it solved the problem and whether it was successfully solved. An effective compliance program goes beyond just correcting the problem. Investigators want to see if firms have investigated the full scope of the deviation — are there any other batches implicated by this deviation? Additionally, they look at what the firm has implemented to prevent similar deviations in the future.
  3. A third key inspectional objective is to assess the laboratory operations. Is there good sample accountability? Are methods well defined and routinely followed? Most importantly — how does the firm react to out-of-specification laboratory results?”

Download the Full Interview with the US FDA

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Following on from this commentary from the US FDA, the 2021 Symposium will be tailored to deliver workshops and best practices from our Senior Consulting team on:

  • Validation
  • Computer System Validation
  • Root Cause Analysis and CAPA
  • GMP Data Integrity
  • Handling Out of Specifications
  • Automated Quality Management


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Download Past Presentations

Computer System Validation


Managing Your QMS and CAPA