What You Should Know About Your CGMP Inspection
By government mandate, the FDA is required to conduct regular cGMP inspections(cGMP I) every year, at different manufacturing establishments that have association with FDA regulated companies. Because pharmaceutical production and quality control is one of the most important functions of the FDA, the government has created Compliance Program Mandate 7346.832 requiring that regular (cMP I) be carried out, by the strictest means necessary, in full compliance with cGMP standards and requirements. This includes pharmaceutical laboratories, or any other manufacturing area that is being used for in-process or finished product testing.
The cGMP inspection may be limited to specific issues regarding your pharmaceutical operation, or may encompass a complete evaluation of your laboratory’s total compliance with cGMP regulations. Whatever the specific objective for your (cGMP I) is, it will be thoroughly explained to you in great detail, before the inspection has taken place. At the minimum, each pharmaceutical quality control laboratory should receive a comprehensive GMP evaluation at least every 2 years as part of your statutory inspection guidelines.
These cGMP inspections may be specific to the methodology being used to test a new product, or a specific aspect of your operation. Or it could be a complete assessment of your entire laboratory’s compliance with cGMP regulations and guidelines. Whatever your cGMP I may include, the most important thing your company can do is to be prepared. CGMP inspections can be some of the most difficult, and heavily scrutinized inspections by the FDA, and they are not to be taken lightly. For your company to succeed in its cGMP inspection, it must be adequately prepared.
The best thing your company can do when making preparations for its (cGMP I) is to consult with an outside pharmaceutical consultancy firm, for the best preparation strategies when dealing with your cGMP inspection. They will be ready to instruct you on the best inspection readiness strategies, as well all the cGMP guidelines and restrictions you should be aware of. They will also help to train your staff, so that they are better suited to answer questions effectively during your cGMP inspection. Adequate preparation cannot be delayed until the last minute when preparing for your cGMP inspection. Your company will need at least 6-12 months of preparatory planning.
It is important to remember that is it the cGMP inspectors job to approach the inspection with the specific job of making sure that your laboratory is achieving consistency and uniformity with all cGMP regulations, as well as being a safe working environment for employees. With this in mind, your company will know exactly what to do, and what needs to be done, to sufficiently pass all (cGMP I). If your company doesn’t take all the preparatory steps necessary, is not ready for the inspection, and fails it, it could cost your company millions in lost product, and could hurt your company’s credibility in the long run. To make sure this doesn’t happen to your company, preparing your staff as soon as possible, gives you your best chance for success.
