Preparation for GMP Audit in Pharmaceuticals : Pharmaguideline

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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 for the audit should be done properly before the audit.

We can plan any GMP audit in following way:

1. Review documents
2. Prepare audit plan
3. Key persons
4. Audit responsibilities
5. Internal audits

GMP Audit planing
1. Review Documents: A list of all documents related to the audit should be prepared. Documents may include batch manufacturing records, master formula records, standard operating procedures, the method of analysis, deviations, change controls, stability testing data etc. 

Qualification documents for the 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 overwriting 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.

2. Prepare GMP audit plan: A plan for the GMP audit should be prepared before the audit, showing the flow of the audit. The 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 weak parts of the department to make the strong before the audit. Visiting schedule of the auditors should be prepared from strongest to the 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 person shall explain the things to the auditors.

4. Audit responsibilities: Area and the work should be allotted to every person of the department. Everyone shall responsible for the completion and correctness of 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 the pharmaceutical industry.

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, 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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9 comments: Post Yours! Read Comment Policy ▼

  1. Good article simple and easy to understand!

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

  3. guideline support for making good documents

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

  5. Very Nice for facing GMP Audit.

  6. v.good guidelines to face any audit

  7. Nice post! thanks for the share in manufacturing audits


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