GMP Audit in Pharmaceuticals

GMP audit of any pharmaceutical industry is very important and crucial in its business. Therefore, before the audit, the preparation of the audit must be done properly.

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

1. Documents reviewed: A list of all documents related to the audit should be prepared. Documents may include batch production records, master formula records, standard operating procedures, methods of analysis, deviations, change control, stability test data, etc.

Qualification documents for water systems, manufacturing equipment and instruments, and quality control, process validation, and analytical method validation must be reviewed prior to a GMP audit.

These documents should be reviewed for completeness, updates, accuracy and overwriting. Supporting data should also be attached, where applicable such as analytical data from quality control and data generated from production and warehouse equipment.

2. Prepare GMP audit plan: A plan for GMP audit should be prepared before the audit, showing the flow of the audit. Each section should focus on strengths that will be shown to the auditor. Before the audit, the strongest and weakest parts of the department should be noted and work should be done to strengthen the weak parts of the department. Inspection schedule of inspectors should be prepared from strong to weak sections of the plant.

3. Key person: One or two persons from each department should be selected as the key person who has complete knowledge about the documents and systems of the department. These key persons will explain the issues to the auditors.

4. Audit Responsibilities: Each person in the department should be assigned areas and tasks. Everyone will be responsible for the completion and accuracy of assigned work. Prior to the audit, the Head of Department should confirm the completion of assigned work.

5. Internal Audit: Internal audit should be done before GMP audit to ensure audit readiness. It will also increase the confidence level of the people facing the audit. Internal audit is the foundation of a successful audit.

These are some of the key points for a successful GMP audit. I think this will help you to face GMP audit in pharmaceutical industry.

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