RISK ASSESSMENT
In all three analytical sets, the key to reducing costs without compromising compliance is the ability to accurately assess
risk, enabling the organization to optimize resources in high-risk areas and save resources in low-risk areas. When assessing
the risk of reducing or eliminating a specification or eliminating an analytical method, four questions must be asked:
- Does the specification or method provide information about the efficacy, safety, purity, or potency of the finished product?
If not, the specification or method should be reconsidered.
- Has the method ever predicted or prevented a compliance issue? If not, then it is likely adding little value.
- What would be the regulatory impact of eliminating or reducing the method? Would the benefits of eliminating or reducing it
outweigh the regulatory hurdles that would have to be cleared?
- What is the cost of a batch failure versus the cost of testing? Is the frequency of batch failure statistically low that it
is more cost effective to "eat" one batch whereas the cost to test each batch may far exceed the cost of the one failed batch?
If the testing of each individual batch can indicate a trend that can reduce or eliminate batch failure, then it may be worth
considering implementing the testing of a statistical number of batches to determine if a trend is being observed. This approach
can reduce the cost of testing (occasional testing versus every batch) and reduce the probability of a failed batch.
Because FDA started promoting quality risk management as part of its 21st century cGMP initiative, risk-based approaches to all aspects of biopharmaceutical operations have become more familiar
and widespread. Analytical testing should be no exception. Although early-stage development personnel do not need to be in
full GMP mode, they do need to understand more fully what is required for compliance, and just as importantly, what is not
required. In fact, development personnel are increasingly undergoing GMP training for just that reason. Similarly, personnel
responsible for legacy products are increasingly reviewing them for accretions of unnecessary testing. As companies who emulate
them will find, significant cost savings and confidence in compliance do not have to be mutually exclusive.
J. Michael Rutledge, RPh, PhD, and Chet Meyers, PhD, are both managing consultants at Tunnell Consulting, Inc.
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