Product-specific preapproval inspections

An inspection by a regulatory body will probably be one that receives the most attention and preparation activities. These audits can be focused [such as a preapproval inspection (PAI)] on a specific product general (an overall evaluation of processes, products, and procedures), or a combination of both. These points are some general areas of inspection and should be considered a good basis of preparation, but are not all-inclusive of the questions routinely asked by auditors. 

Compliance members, with the help of analytical members of the preapproval audit inspection team, audit the following product-specific documents ... 

A product-specific checklist should be prepared to assist in preparation for a preapproval inspection. 

Audits of the stability program by a quality unit within the organization should be conducted routinely and should include verification of the data collected for the studies presented in reports. In addition, regulatory agencies will conduct inspections of programs and facilities prior to the approval of a specific product (preapproval inspection or PAI) or as a routine inspection of a facility (general GMP inspection). 

Product stability Inspection of the establishment to determine compliance with cGMP requirements and to conduct an audit of the data furnished to CDER in the application is a Field responsibility. This requirement applies to both the relevant preapproval batches, as discussed above, and the proposed commercial batches. CDER application review chemists are responsible for review of the proposed drug product stability protocol, specifications, and evaluation of the data submitted in support of the expira-... 

Once an equivalent authority receives an inspection report from another equivalent authority (post- or preapproval reports), the receiving authority will normally endorse the report, except under specific and delineated circumstances (e.g., material inconsistencies or inadequacies in inspection report, quality defects identified in postmarket surveillance, and specific evidence of serious concern in relation to product quality or consumer safety [39]. In these exceptional cases, the importing country s regulatory authority may request clarification from the exporting country, which could result in a request for reinspection. In addition, the importing country might conduct its own inspection of the production facility if attempts at clarification are not successful [40]. 

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