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. 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? 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.
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?
