FDA’s Quality System Approach

Since the pilot program from January 01, 2001 to June 30, 2001 FDA is using more and more the Quality System Approach during its domestic and international inspections of drug products, API and device manufactures.
Investigators undertook a specific training program on using the Quality System Approach and were trained in particular how to audit each the following subsystems:

• Quality System
• Facilities and Equipment System
• Materials System
• Production System
• Packaging and Labelling System
• Laboratory Control System

The system approach was designed to enhance the efficiency and consistency of the FDA field operations and to optimise the use of limited inspection resources.
The FDA anticipates that the shift from a product-specific to a plant wide GMP compliance focus should lead to the need for fewer repeat inspections and should also help facilitate the plan to decrease the number and depth of Pre Approval Inspections. The standardized approach should also provide an overall picture over the quality compliance of the inspected plant as well as the quality mindset and commitment of the holding company. 
An indication for this is that FDA intends to set-up a unit that will use the new inspection data to focus on problem identification and action mapping.

With their focus on PAI work and the resource crunch, the FDA feels they have drifted away from a more generalized GMP coverage.
The approach brings Devices API and Drug Product into one conceptual model and therefore provides a tool for combination type products and focuses the FDA’s ways of work.

What is different from the past? Nothing in the previous inspection program prevented inspectors from taking a “system approach”. FDA just formalized their inspection tactic to reach more efficiency and to standardize the inspection procedure. Investigators have now to cover at least two or more systems with mandatory coverage of the Quality System. This brings FDA into the position to do a kind of “bench marking” and to get a clear picture about the industries current practices.

But this does not mean that FDA is decreasing their Pre Approval Inspection activities automatically. They will still be doing PAIs, but these may be more focused on general systems including data verification / integrity and will be therefore more efficient than before.

There are two different inspection types, the Full Coverage means it is mandatory to audit the Quality System itself plus at least three other systems. The Abbreviated Coverage means the Quality System itself plus at least one other system.

The “Full Coverage” is used whenever there is no information on the firm’s GMP status, mostly for the initial inspection or when significant changes have occurred. Other reasons are when there are doubts about the firm’s GMP compliance based on history or to follow-up on previous regulatory actions e.g. warning letters.

The “Abbreviated Coverage” is carried out for surveillance or routine coverage. This is the case when there are a few or no changes in products or processes or when significant objectionable conditions (system failure) are found during full coverage.

But be careful! FDA is not required to announce whether the inspection will be full or abbreviated OR what systems will be covered. So, in any case you have to be prepared and compliant in all areas.

An interesting and new aspect of the Quality System Approach is that the coverage of the inspection will be completed as planned unless the investigator and/or document sufficient evidence to constitute a system failure. (Note: Need District concurrence to stop inspection.) This is also a hint that FDA efforts to collect data, to get a whole picture of the plant and the company’s compliance status.

At least the goal of the Quality System Approach remains the same:

“Evaluate whether management with executive responsibility ensures that an adequate and effective quality system has been established and maintained.” And “ensure to minimize consumers exposure to adulterated drug products.”

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