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USFDA Guidances: Preapproval Inspections & Drug Manufacturing Inspections

The USFDA recently revised two compliance programs, which will go into effect from, October 17, 2022:

Preapproval Inspections (PAI) cover new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and Drug Manufacturing Inspections (NDAs) provide coverage for surveillance inspection of drug manufacturing establishments based on current good manufacturing practices.

There was primarily a revision to both compliance programs with information related to the ICH guidances for industry Q9 Quality Risk Management, Q10 Pharmaceutical Quality System, and Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; control of nitrosamine impurities; and alternative tools for assessing facilities relevant to the inspection.

The purpose of preapproval facility evaluations and inspections is to ensure that any establishment named in or referred to in support of a marketing application can perform the proposed manufacturing operations according to CGMP requirements and that the data submitted in the application is accurate and complete.

The Drug Manufacturing Inspections goal of this compliance program’s activities is to ensure that establishments consistently manufacture drug products of acceptable quality and minimize consumers’ exposure to adulterated drug products.


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