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 21 CFR/211, including 21 CFR part 600 for biologicals, as well as the relevant ICH guidelines.

These might include ICH Q7A for API manufacturers, ICH Q9 for Risk Analysis and Management, ICH Q 10 for Quality Systems and ICH Q 11 for Manufacturing. This is referred to as a pre- approval inspection or PAI.

There is a third option, and this could include a “For cause” inspection following a recall or a bad previous inspection, where a significant 483 or Warning Letter was given for example. Depending upon the severity of this, the FDA might classify these inspection outcomes as requiring, no action required (NAI), voluntary action required (VAI), or official action required (OAI). These latter two categories require the company to do something significant to improve the operational practices and in the case of official action required, this may involve outside help from an external pharmaceutical consultant to get the company back on track.

Once you understand the type of inspection you will experience, one can begin to plan.

Fundamental to inspections must be the commitment from the company and its senior management to operate within the regulations, and upon this premise, the FDA will expect companies to provide systems and mechanisms to assure control of their plants, processes and product quality. In all cases, these will need to be consistent to meet proper compliance expectations.

The underlying philosophy of manufacturing drugs/therapeutics is that one delivers the product via a macro process, where quality is built into every facet of the product’s manufacture. This literally means having control of all the elements which go into the manufacture of a product and that this is made possible through ensuring that systems exist to monitor performance. Central to this process to ensure that quality is built into the process, is the Quality Management System (QMS). Of all the pieces involved for an inspection of any of the previously mentioned categories, is the need to assure that this QMS is complete and current in terms of all of its elements.

Making sure that these critical elements are in place is the first step in the preparation process.

By way of a summary, key process elements which make up this quality management system (QMS), should include but not necessarily limited to:

Change Management, Deviations/Investigations, CAPA (Corrective Action Preventive Action), Training, Validation, Maintenance/Calibration, Document Control, Documentation Practices, Laboratory Systems, Manufacturing Controls, Supplier Management, Warehousing Controls, Disposition Release and Quality Assurance.

The basic premise of the QMS is that each element works in harmony in an overlapping sense to assure that the manufacturing process works within defined limits, which are predictable and reproducible. As a system check, it’s a good idea to review this at least semiannually with a fresh pair of eyes from an outside source, such as a knowledgeable consultant.

Continue reading Part 2 here.