Author: Nigel J Smart PhD

Strategy for FDA Inspection Process; Part 5

……being well prepared is the most effective strategy for success! As previously mentioned, eradicating entry points or exposure points for selected data and information will play a major part in your strategy for a successful FDA inspection. The agency is looking to test your quality management system to see if it proves effective in helping your site to remain in compliance. Immediate in that inspection strategy is to define exposure points, or points of weakness which then can be used to rigorously evaluate how well you are doing. In the first instance then they’re looking to build a high-level...

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Delivering Success in an FDA Inspection Process – Part 4

—-Be prepared, the FDA cometh! Preparing for the FDA is key and underpinning for success in navigating the inspection process. Most important is to pick the right core team to help prepare the site for the process. After the fact, this team can also be helpful in maintaining processes so that things are always in a good state of readiness. This can prove to be a welcome bonus! Important is to make sure that the team and its members are clear in terms of their responsibilities. In preparing a good strategy,it is to important to spend a budgeted amount...

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Delivering Success in an FDA Inspection Process – Part 3

—-Be prepared, the FDA cometh! In preparing for your facility audit, the FDA will spend up to 16 hours covering information from a variety of sources. They will look at your product submissions and registrations, key suppliers and collaborators, like your CMOs and testing houses that you may be using your product. They will look at your previous inspection history, including any 483’s, previous EIR’s, Warning Letters or import bans that may have occurred or have been accumulated. The records that may be searched would include any recalls that have been sustained, adverse event history and financial information such...

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Delivering Success in an FDA Inspection Process – Part 2

So, when the FDA arrives at your facility, the inspection team will present their credentials, which includes their badge and they will request to see the responsible person. When the responsible person arrives, which is usually the head of the site QA group, they will present form 482 which states why they are at your facility. They will request a meeting to discuss the pending inspection and your job is to escort them to a suitable room that is prepared as home base for the FDA site inspection team. Note; at all times the inspection team will be watching...

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Delivering Success in an FDA Inspection Process – Part 1

So, you’re going to have an FDA inspection? Why is this going to happen? Either you have a registered licensed product or you’re in the process of obtaining a product approval. In each case the FDA will be interested to inspect. In the case of the licensed product; to assure you are still operating according to 21 CFR part 210/211 regulations and various ICH guidelines. Typically, these inspections are determined general GMP inspections, auditing for current good manufacturing practices, (cGMP). In the case of a new drug approval, the agency is looking to assure you meet current expectations for...

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