POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 172

and ineffective commissioning practices can also result in systems that cannot
or do not function as expected. Qualification programs should be designed to
assure the required function of any, all, and only facility and equipment features
that could affect product quality. A good qualification program will do this in
an effective and efficient manner, utilizing all reliable sources of information,
including where applicable prequalification information and sources.
Risk assessment may be used to eliminate redundant and limited value efforts,
such as those involved with the qualification of items that pose no risk to prod-
uct quality or patient safety. It may also be used to provide guidance on the
leveraging of information from prequalification efforts such as design, fabrica-
tion, construction, installation, acceptance testing, and commissioning. In doing
so, risk assessments provide a valuable tool for developing and executing an
effective and efficient qualification program.
It is an expectation of many regulatory agencies that companies consider risk to
product quality and patient safety when making product manufacturing decisions.
These expectations are reflected in recent FDA guidance and industry standard
guides. The specific method for considering or assessing risk is largely left to the
companies. In most cases, it is not essential that a particular method or tool be
employed, rather that some logical method for considering risk be used. Many of
the methods and tools discussed in other chapters may be found to be useful for
the assessment of risk with respect to qualification, including FMEA and FMECA
(failure mode effects and criticality analysis), Ishikawa or fishbone analysis, fault
tree analysis, and impact assessments.
This chapter has attempted to present some suggestions and points to consider
when developing a risk-based qualification program. It was not meant to give an
exhaustive or prescriptive procedure for qualification or to cover all topics related
to the qualification of pharmaceutical facilities, equipment, and systems. Rather, it
is the hope of the authors that the reader will be able to use the information in this
chapter to formulate better plans and more pragmatic programs for qualification
efforts based on risk and science.
REFERENCES
1. Department of Health and Human Services, U.S. Food and Drug Administration, Code
of Federal Regulation, Title 21, Chapters 210 and 211, Section 100 (CFR 211.100 of
cGMPs), 2008.
2. Department of Health and Human Services, U.S. Food and Drug Administration,
Guidance for Industry on the General Principles of Process Validation, January 2011.
3. Department of Health and Human Services, U.S. Food and Drug Administration,
Guidance for Industry on the General Principles of Process Validation, January 2011,
page 10.
4. Department of Health and Human Services, U.S. Food and Drug Administration,
Warning Letter to Bell-More Laboratories, Inc., January 5, 2007.
5. ASTM (American Society for Testing and Methodology) E2500-07, Standard Guide
for Standard Guide for Specification, Design, and Verification of Pharmaceutical and
Biopharmaceutical Manufacturing Systems and Equipment.