Drug products preapproval inspections

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-... 

The review of validation studies on various drug products has a high priority for the regulatory authorities during preapproval inspection and routine biannual inspection. 

Preapproval inspection has always been part of the FDA s armory of enforcement. Formerly it was commonly used only in connection with newly constructed facilities, or where existing facilities had never been inspected before, or where a period of two years had elapsed since a previous inspection on a similar dosage form. All of these criteria still apply, but all new chemical entities must be preapproved for products currently being distributed, the top 200 are to be inspected for approval, and drugs with a narrow therapeutic range are to be preapproved. 

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