FDA addresses retention of Internal Audit Reports
Do the CGMP regulations permit the destruction of an internal quality assurance
audit report once the corrective action has been completed?
The CGMP regulations (21 CFR 210 and 211) for finished pharmaceutical manufacturing
do not specifically address the requirement to conduct, or to keep records of, internal
quality assurance audits. If the report in question were from a routine audit to verify that
the firm's quality system is operating as intended, then it would be acceptable if the firm
elected to discard the report once all corrections have been verified.
However, any documentation of corrective action as a result of such an audit would have
to be retained (see 211.180 and 211.188). For example, if a routine internal audit finds a
problem with a mixing step and the outcome is a change in mixing time, all affected
procedures, including the master production record, are to reflect the necessary changes,
and such records are subject to FDA inspection as usual. Any investigation into the
impact this problem had on related batches is to be retained and also made available for
inspection by FDA (see 211.192).
In addition, any reports of investigations or evaluations prepared in response to, for
example, a product complaint (211.198), vendor qualification (211.84), periodic review
of records and data (211.180(e)), and a failure investigation (211.192) are not internal
audits as discussed above. Such records are subject to FDA inspection and must be
retained for at least the time specified in the CGMP regulations (see 211.180).
References:
Preamble to the Current Good Manufacturing Practice in Manufacturing,
Processing, Packing, or Holding regulations; Federal Register, September 29,
1978 (vol. 43, no. 190), page 45015, paragraph 4 https://www.fda.gov/cder/dmpq
21 CFR 211.84: Testing and approval/rejection of components, drug product
containers, and closures
21 CFR 211.180: General requirements
21 CFR 211.192: Production record review
21 CFR 211.198: Complaint files
Compliance Policy Guide Sec. 130-300, (7151.02)
https://www.fda.gov/ora/compliance_ref/cpg/cpggenl/cpg130-300.html
Contact for further information:
Rosa Motta, CDER
rosa.motta@fda.hhs.gov
FDA addresses retention of Internal Audit Reports - Read FDA's response to a question regarding retention of Internal Audit Reports