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-- Has the FDA lost its Objective? --

Historically if an FDA investigator that a company was ISO9000 Certified or that a supplier was ISO 9000 Certified, they would make remarks such as, "So what does that prove?" and furthermore, "The FDA does not recognize ISO as an indication of GMP compliance." Judging from the opinions of all the FDA'ers met and spoken with both in the field and in Washington, an ISO audit could not match a GMP audit when you assurance quality of medical product quality was at stake.

One has to understand the premise of the FDA mandate as compared to the ISO9000 idea. It is a violation of the Food, Drug and Cosmetic Act as Amended, to ship an adulterated product into interstate commerce. This adulteration can occurr

When a device or drug has not met specifications but is still shipped. Adulteration exists here whether or not the shipment was made deliberately or in error.
Even if a device or drug is found to meet specifications, but its manufacturing procedures are not in GMP compliance.

Now, of course one could understand how the regulations are applied to the first situation above. But, the second point is a very serious one and has long lasting implications for the medical industry. If the FDA documents, during an inspection, that a quality system is not in compliance with the cGMP and even though, they could not demonstrate that the device failed any testing or did not meet specifications, the FDA could find those products to be adulterated based on this lack of cGMP compliance.

The ISO 9000 standard for a quality system does not apply to the product. ISO 9000 was set up to provide the customer that level of satisfaction that can be provided -i.e. "what they ordered". If not one would do whatever would be necessary to satisfy them. Though, an ISO audit does address inspection and testing of finished products, there is no requirement that "only products that meet specifications are shipped." As a matter of fact, in one part of the ISO standard, it allows a manufacturer to ship product that they feel may not meets the specifications, with the capability of recalling it, if necessary. This is being done in the name of Customer Satisfaction.

This goes against the FDA regulatory requirements and the GMP. This is why the FDA has always dismissed the ISO Certification as not being equivalent to GMP compliance.

This being said, why is it that the FDA is so intent on this new inspectional strategy - QSIT. One could understand that the old format was not being fairly implemented throughout the nation by different investigators, but to use the fact that the FDA wants to be harmonized with the European Community as a reason for making this change is ludicrous.

One could understand why the FDA would like to use a top-down approach to their inspections and place more responsibility on the top management (though the FDA always had the power to take top management to task in the event of a failed quality system). However, if the FDA decides to use the ISO approach as their own inspectional approach, one could take this to be an unfortunate turn of events and one which might have dire circumstances.

As an internationally certified lead assessor for ISO9000 as well as being involved with FDA GMPs inspections for the last 27 years - I believe this could represent a potential problem for the US consumer who has come to rely on the FDA to assure that the medical industry provides a product that meets specifications. In the recent past, FDA inspections have gotten away from reviewing the entire quality system, but, they did look at the products and try to evaluate whether the products had been made to specifications. They questioned the processes and the testing parameters and addressed how the products are being manufactured. ISO audits do not do this, especially during surveillance audits conducted by ISO certified bodies.

Evaluating the revised GMP (1997), the FDA has used very similar terminology for many of the sections. But, this document has addressed many of the areas that the FDA had felt needed attention, i.e. process validation and MDR.

One could look at this Revised GMP as a higher level document than the ISO9000 standard. It provides a closer harmonization of the two standards, which was one of the objectives of the FDA for this rewrite.

It would appear that the change in the FDA's inspectional policy to use the QSIT was to make the inspections more uniform and provide clear cut guidance for investigators. But, if the FDA plans to conduct their inspections in a similar manner as the ISO audits, then the FDA's change in inspectional policy is one that will not provide them the review that they are seeking. One can be sure that ISO Certification audits are not FDA inspectional audits. If the FDA gives up their review of product production practices and documentation, can the FDA be sure that they will be able to provide the American Public with the quality products to which they are accustomed? This will remain to be seen. Unfortunately, discovery of the outcome could come at the expense of some unaware consumer or patient. Let's hope not.

Next Month’s Insight Report –

The next Insight Report Vol. 3 #2

China - The Workforce for the Future.

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