In the case of product-related inspection (in particular, preauthorization)
depending on the complexity of the product and/or process, greater collaboration
between inspectors and assessors could be helpful (for example, for the
assessment of development data). The inspection would normally occur at the
proposed commercial manufacturing site, and there is likely to be greater focus on
enhanced process understanding and understanding relationships, e.g., critical
quality attributes (CQAs), critical process parameters (CPPs). The inspection
might also focus on the application and implementation of quality risk
management principles, as supported by the pharmaceutical quality system (PQS).
