Custom Search

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).

We encourage you to subscribe to this website by entering your email id , to receive all articles over this website by email when ever this website is updated .
Regulatory affairs in pharmaceutical industry

Following are some of articles which;will be useful for you in further understanding of aspects of sterile dosage form manufacturing

Pharmaceutical Validation

Cleen Room Classification

Pharmaceutical Industry

Pharmaceutical Manufacturing

Clinical Trials

Media fill

Regulatory Affairs in Pharmaceutical Industry

No comments:

How to successfuly activate and receive our articles on pharmaceuticals by E-Mail

Dear readers if you wish to receive our articles on pharmaceutical automatically into your email Inbox , as and when we write a new article over this website, then follow these 3 simple steps.

1.You should write your Email ID in the box provided and push the subscribe button

2.Enter the text code that we show you in a small new browser window after you enter your email ID.

3.Log in to your email and Check our verification email sent by "FEEDBURNER" , there you should verify the link we send you by email.

Enter your email address get our articles by email whenever this website is updated

Delivered by FeedBurner

Join the list of our readers from Universities ,Research and
Development centers Pharmaceutical Companies from all over the world.

Pharma Research Regulatory Guidelines Website
Texas Dallas, TX 75211 US
Email: Website:
Copyright © 2008-2020 all rights reserve