How to Plan for a GMP Audit in Pharmaceutical Industries?

GMP audit of any pharmaceutical industry is very critical and essential in terms of its business. Therefore, the preparations for the audit should be done properly before the audit.

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

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, methods 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 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 audit plan: A plan for the audit should be prepared before the audit, showing the flow of the audit. Every department’s strength should be focused and 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 the strongest to the weakest department of the plant.

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

4. Audit responsibilities: Area and work should be allotted to every person in the department. Everyone shall be responsible for the completion and correctness of the allotted work. The 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. (Source: Pharma Tips)

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