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Preparation for GMP Audit in Pharmaceuticals

Planning for the GMP audit in pharmaceuticals including document review and internal audits.
GMP audit of any pharmaceutical industry is very critical and important in the terms of its business. Therefore, the preparations of the audit should be done properly before the audit.

GMP Audit planingWe can plan any GMP audit in following way:
1. Review documents
2. Prepare audit plan
3. Key persons
4. Audit responsibilities
5. Internal audits

1. Review Documents: A list of the all documents related to the audit should be prepared. Documents may include batch manufacturing records, master formula records, standard operating procedures, method of analysis, deviations, change controls, stability testing data etc. Qualification documents for water system, equipment and instruments of production and quality control, process validation and analytical method validation must be reviewed before the GMP audit.
These documents should review for the completion, updating, correctness and over writing also. Supporting data should also be attached, where is it applicable such as analytical data from quality control and data generated from the production and warehouse equipment.

Related: GMP for Sterile Pharmaceutical Manufacturing

2. Prepare GMP audit plan: A plan for the GMP audit should be prepared before the audit, showing the flow of the audit. Strength of every department should be focused that shall be shown to the auditor. The strongest and weakest parts of the department should be noted and work should be done on the week parts of the department to make the strong before the audit. Visiting schedule of the auditors should be prepared from strongest to weakest department of the plant.

3. Key persons: One or two persons of every department having the full knowledge about the documents and system of the department should be selected as the key person. These key persons shell explain the things to the auditors.

4. Audit responsibilities: Area and the work should be allotted to the every person of the department. Everyone shall responsible for the completion and correctness for the allotted work. Head of the department should ensure the completion of the allotted work before the audit.

5. Internal audits: Internal audits should be conducted before the GMP audit to ensure the audit preparations. It shall also increase the confidence level of the persons facing the audit. Internal audits are the foundation of a successful audit.

These are some major points to make a GMP audit successful. I think this shall help you to face a GMP audit in pharmaceutical industry. You can write your views in comment box.

Also see: Common Ways to Avoid Making the Most Frequent GMP Errors

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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dadasaheb deshmukh said... on 14/10/13 08:37

Good article simple and easy to understand!

M.V.suryanarayana sastry Qa said... on 15/10/13 11:24

Good article & a nice pathway guide in a nut shell to prepare for the gmp audits.

Laxmi Tiwari said... on 21/10/13 10:59

guideline support for making good documents

nimesh trivedi said... on 11/11/13 22:42

Very good and most helpful article to prepare for GMP audit.
thanks for that.

K.R Rajavel said... on 8/5/14 07:07


sandeep shakya said... on 18/5/14 18:22

Very Nice for facing GMP Audit.

anand.p said... on 29/4/16 20:12


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