Regulatory Inspection Trends

An important aspect of this new approach is the expectation that pharmaceutical and healthcare companies will implement any corrective actions identified as the result of a site inspection across the whole of their operations. Effective coordination of corrective actions is vital for large multinational organizations. An example form that might be used to collate computer validation inspection history is presented in Table 16.1. The FDA and MHRA already have access to inspection databases and have the ability to readily trend data and track repeated offences on particular topics across multiple sites in a firm s organization. Indeed, regulatory authorities may in the future share inspection findings with the MRA parmer regulatory authorities. 

Once a vial has been filled with powder, it is stoppered and transported out of the sterile area, and is capped. The current regulatory trend is to perform the capping operation in a sterile area using sterilized caps. After capping, vials are usually visually inspected, labeled, and packaged. 

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