The CGMP regulations (21 CFR parts 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 was 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:

• 21 CFR 211.84: Testing and approval/rejection of components, drug product containers, and closures
• 21 CFR 211.180: General requirements
• 21 CFR 211.188: Batch production and control records
• 21 CFR 211.192: Production record review
• 21 CFR 211.198: Complaint files
• Preamble to the Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding regulations (43 FR 45015, paragraph 4, Sept 29, 1978)
• Compliance Policy Guide Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections (CPG 7151.02)