Introduction
This part provides an overview of the development of several kinds of GXP training modules.
The preceding chapters have presented three main topics:
1. A problem is observed in a manufacturing process, and an investigation and root cause analysis (RCA) may ensue. The investigation may lead to the development and execution of a CAPA plan. The CAPA plan may lead to revisions of the process and associated procedures (SOPs).
2. Should a SOP be revised as a result of CAPA, it should be subjected to critical review to ensure that the revision adds value. In light of the complexity and criticality of the process that is reflected in the SOP, the review can take one of several forms – it can be a management review, a SME review, a real-world ...
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