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It is the responsibility of the FDA to ensure that pharmaceutical products are safe and effective. To ensure this, the FDA inspects the pharmaceutical manufacturing facilities. This inspection of pharmaceutical manufacturing facilities is known as regulatory inspection. There are some important things to remember in the preparation of FDA inspection. In this article, we will share the same tips to prepare for a successful FDA inspection and its follow-up.
What is an FDA Inspection?
FDA inspections are conducted by the United States Food and Drug Administration by sending a team of expert inspectors to review the pharmaceutical manufacturing facility. The main goal of the inspection is to verify that the manufacturing facility is in compliance with the FDA standards and that the products are of high quality. A successful FDA audit indicates that the products of a company are safe and effective.
What does the FDA Inspect?
During the inspection, FDA ensures that the facility is in compliance with current good manufacturing practices (cGMP) regulations. FDA reviews the facility operations, manufacturing process, quality control testing and validation documentation. They also review the training programs conducted for employees.
Planning of FDA inspection
FDA inspects pharmaceutical manufacturing facilities to determine that the facility follows the good manufacturing practices regulations. A careful planning and execution are required to complete an FDA inspection successfully. Following are some useful tips to help in preparation for an FDA inspection.
1. Review all the SOPs in the facility and ensure that they are up to date.
2. Understand the FDA’s good manufacturing practices guidelines and find the gap between guidelines and SOPs. If there are any gaps, revise the SOPs accordingly.
3. Self-inspections are useful to find the deficiencies in the implementation of GMP guidelines in the facility. Comply the gaps found during the self-inspection before the FDA inspectors find those.
4. Prepare employees to answer the questions the inspectors may ask. The inspectors may ask questions about the SOPs and manufacturing procedures during their visit.
5. Ensure that all deviations and change controls are closed and complete and their preventive measures are implemented.
