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Tuesday, September 15, 2009

Internal quality assurance audit report CGMP regulations

Can we destroy an internal quality assurance audit report after the corrective actions taken and  compliance are achieved do CGMP regulations allows this?

If the internal audit is a regular one  to ascertain the quality control , quality assurance , manufacturing process, systems are functioning as desired by CGMP guidelines , and there is no noncompliance observed , then one can discard the report once all corrections have been verified.

But it should be retained in cases where there is any non compliance is observed , and further documents which will ensure that the corrective action is taken and the any noncompliace is complied , (Give reports)

US FDA has provided answer to above question with explanation as follows.

The Current Good manufacturing practice regulations (CGMP )(21 CFR 210 and 211) for finished pharmaceutical manufacturing don't 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).


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