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Changes to Compliance Program
Guidance Manual (CPGM) 7346.832:
Preapproval Inspections/Investigations, Part II Implementation
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Inspection Categories that Would Prompt a Preapproval Inspection
This is to inform District Preapproval Managers and those Field
personnel who conduct preapproval inspections of the changes CDER
has made to the Preapproval Inspection/Investigation CPGM. The
Implementation portion of CPGM 7346.832 has been updated to
incorporate a risk based approach consistent with the Agency's GMPs
for the 21st Century Initiative in order to help reduce the number
of preapproval inspections and leverage preapproval resources, where
practical, for post approval and/or CGMP coverage.
The strategy for assigning PAIs now includes two general
categories, those that will regularly prompt an inspection request
from CDER and categories where the district office may choose to
perform an inspection. This revised inspection strategy provides ORA
Field Offices greater flexibility in determining if a preapproval
inspection is necessary based on the most current knowledge and cGMP
status of a firm. Additional changes include the deletion of the
inspection categories for narrow therapeutic range drugs and generic
versions of the top 200 most-prescribed drugs.
These changes are effective immediately and have been
incorporated into Compliance
Program 7346.832.
CDER is anticipating additional changes to the remainder of the
Preapproval Inspection/Investigation CPGM. However, FDA determined
that these changes are needed immediately to allow greater use of
risk-based decisions in the assignment and conduct of preapproval
inspections.
The revision to the CPGM was also discussed in the 9/3/2003 FDA
Press Release regarding the progress of FDA’s Risk Based
Approach to Pharmaceutical GMP for the 21st Century.
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Date created: September 5, 2003 |
