Answers:
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.
