Biomedical Engineering Reference
In-Depth Information
The probability of the event is described by high, moderate, and low. The
probability that a lower inhibitor concentration can allow bacterial growth (D)
is considered high without further study. The probability that bacteria will be
present in sufficient concentration to grow (E) is low because of cleaning proce-
dures associated with the resin manufacture. Since both a low enough inhibitor
concentration (D) and bacteria present in sufficient concentration (E) are needed
to allow unacceptable growth, the overall risk is moderate. The probability that
the resin will be chemically changed (C) is low, as it typically does not need the
inhibitor to chemically preserve it.
The analysis of the FTA chart leads to the conclusion that key element is (D)
to inhibit bacterial growth. A study may prove that a certain concentration of the
inhibitor may be high enough to inhibit bacterial growth while being low enough
to address the process safety concerns.
13.8 CONCLUSION
The benefits of integrating QRM into the change control system include improved
risk communication, faster and more thorough science-based evaluations, and
increased productivity.
Integrating QRM should not be difficult. Routine changes may be initially
assessed from a risk perspective and then managed through administrative con-
trols such as simple procedures. More complex changes can be assessed and
managed using tools that are commonly accepted in industry, such as FMEA or
FTA. Keys to successful implementation include a defined methodology, team-
work, and management commitment.
QRM ultimately focuses on risk to patients. Product quality and regulatory
compliance may be used as acceptable surrogates for
risk to patients
. The use
of QRM demonstrates to regulatory agencies that a company understands its
products and has all of its processes under control.
REFERENCES
1. FDA Guidance for Industry: Q9 Quality Risk Management, June 2006.
2. FDA Guidance for Industry: Q10 Pharmaceutical Quality Systems, April 2009.
3. Procedure For Performing A Failure Mode Effect and Criticality Analysis, November
9, 1949, United States Military Procedure, MIL-P-16.
4. Process Safety Management, OSHA 29 CFR 1910.119.
5. FDA Guidance for Industry: Q8 Pharmaceutical Development, May 2006.
6. ISO 14971: Medical Devices-Application of Risk Management to Medical Devices.
