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Reasons for conducting a pre-approval inspection
The purpose of a PAI is to ensure that manufacturing, development and related control facilities meet current GMP, conform to the stipulations of the Code of Federal Regulations (CFR) parts 210, 211, 820 and 11 and are in line with commitments to verify the authenticity and accuracy of data contained in the submitted application file. The inspectors must ensure that product development is carried out in a way that produces reliable process attribute ranges. They must also make sure that all key GMP systems (» FDA system approach) at the development and commercial sites are up to current GMP standards.
New Drug Application (NDA)
The New Drug Application is the registration file sent to the FDA for the marketing of a new drug product in the U.S.
Biologics License Application (BLA)
The Biologics License Application is the equivalent of an NDA for biopharmaceutical and biotechnology products.
Marketing Authorization Application (MAA)
The Marketing Authorization Application is the registration file submitted to the relevant national authorities of EU member states or the EMEA (European Medicines Evaluation Agency) as part of an application to market a new product in the European Union.
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