Guidance for Foreign GMP Inspection

1. Pre-inspection planning

This involves determining the scope and objectives of the inspection, identifying the specific areas to be inspected, and gathering relevant information about the foreign facility.

2. Notification

The regulatory authority or agency conducting the inspection notifies the foreign facility about the upcoming inspection, providing details such as the date, time, and purpose of the inspection.

3. Arrival and entry

The inspection team arrives at the foreign facility and goes through an entry process, which may include presenting identification documents, signing confidentiality agreements, and receiving a briefing on facility operations.

4. Opening meeting

The inspection team holds an opening meeting with facility management to discuss the purpose of the inspection, provide an overview of the inspection process, and address any initial questions or concerns.

5. Facility tour

The inspection team conducts a comprehensive tour of the facility to observe manufacturing processes, storage areas, quality control laboratories, equipment, documentation systems, and other relevant areas.

6. Document review

The inspectors review various documents related to manufacturing processes, quality control procedures, batch records, validation reports, training records, complaint handling systems, and other relevant documentation.

7. Interviews

Inspectors conduct interviews with key personnel involved in manufacturing operations and quality control to gather information about procedures followed, training programs implemented, quality assurance measures taken, and any issues or concerns identified.

8. Sampling and testing

If necessary or deemed appropriate during the inspection process, inspectors may collect samples of raw materials or finished products for further testing in accredited laboratories.

9. Compliance assessment

Inspectors evaluate compliance with Good Manufacturing Practices (GMP) regulations by comparing observed practices with applicable standards and guidelines. They identify any deficiencies or non-compliance issues that need to be addressed by the foreign facility.

10. Closing meeting

The inspection team holds a closing meeting with facility management to discuss their findings and observations during the inspection. They may provide recommendations for improvement or corrective actions if any non-compliance issues were identified.

11. Inspection report

The inspection team prepares a detailed report summarizing their findings, observations, and recommendations. This report is submitted to the regulatory authority or agency conducting the inspection.

12. Follow-up actions

Based on the inspection report, the regulatory authority may take appropriate actions, such as issuing warning letters, imposing penalties, requesting corrective actions, or conducting further inspections to ensure compliance with GMP regulations.

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