Which Firms Will the FDA Inspect More Frequently in the Future?

GMP News No. 579

GMP News
25 July 2005

Which Firms Will the FDA Inspect More Frequently in the Future?

For some time now, the FDA has been discussing which firms have to be inspected more frequently and which ones can be inspected less frequently.For this reason, the Agency called an internal meeting during which members of an Advisory Board were asked questions. The Advisory Board regularly gives advice on regulatory topics to the FDA. The members of the Advisory Board are among others representatives from the industry or experts from universities. In the following you can read answers given by the Advisory Board on how manufacturing sites can be prioritised systematically for GMP inspections.


Can you identify alternative approaches that would systematically prioritize manufacturing sites for GMP inspections?


One member suggested distinguishing between different risks associated with the products and processing lines, although the Subcommittee recognized the importance of an effective quality system associated with pharmaceutical production.

One member suggested the use of a decision tree in order to prioritize sites according to the expected utilities.

In addition, the Subcommittee recommended that FDA consider the distribution of sites selected by the model to consider whether there is a representative balance between generic and innovator sites and between biotech and conventional manufacturing sites.

In what areas would additional data provide the most value added in prioritizing manufacturing sites for GMP inspections?

One member expressed concern that high volume of production should not be given too much weight as a criterion to prioritize sites for inspection and suggested a "volume-risk index" that would fully take into account factors that mitigate risks, some of which may be associated with high volume production.

The Subcommittee emphasized that historical inconsistency among investigator findings might limit the utility of such findings in prioritizing sites for inspection, but the Subcommittee recognized that this limitation should become less problematic over time as the new Pharmaceutical Inspectorate program is implemented.

The Subcommittee agreed that it would be crucial to ensure that the model promotes the correct incentives that encourage robust quality systems, continued availability of medically important drugs, and continuous improvement.

Are there other metrics that should be incorporated, e.g., measuring process control?

The members felt that companies with a high turnover of personnel might be a helpful indicator to include but that it may be difficult to obtain good data on this factor. One member stated that expert testimonies are a positive step in the agency's risk-based analyses, but wanted to ensure that such testimonies would be formally incorporated into the analyses.

The members highlighted that understanding of high-risk areas is a helpful tool for both FDA and industry in allocating resources. The members emphasized that FDA needs to help industry understand the model ranking factors with appropriate transparency, to allow firms to improve their ranking by moving toward the desired state, and to allow them to appropriately allocate their internal resources.

If you do not yet know the pilot programme of FDA, we recommend you to have a look at the presentation by Nga Tran (Exponent) and Brian J. Hasselbalch (FDA). Please click here.

Source: www.fda.gov

The subject of risk-based inspections by FDA is an integral part of the 3-day intensive course:

How to Pass EU and FDA Inspections - GMP Compliance Auditor Course
Prague, Czech Republic
16-18 November 2005

Compiled by: Oliver Schmidt, CONCEPT HEIDELBERG

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