POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 129

7.1.2 Risk-Based Qualification and Assurance of Quality
Proving assurance is to make certain, provide confidence, and remove doubt or
to be free from doubt. In the context of our industry, assurance can be achieved
by observation or prediction. Observation or verification is the confirmation by
examination and provision of objective evidence that specified requirements have
been fulfilled. One is assured that something exists because one can see it, observe
it, and test it. If one cannot observe something, then one must predict that it will
happen or has happened. Confidence in the prediction of an outcome based on
observation or evaluation of sampling is a key element of pharmaceutical PV.
Validation and qualification are ways to provide assurance of product quality
through assurance of process performance validation, or qualification is confir-
mation by examination and objective evidence that the particular requirements for
a specific intended use can be consistently fulfilled. In other words, validation is
a combination of what can be verified and our confidence that even with reduced
verification, that condition will still exist. Put another way, validation or qualifi-
cation is prediction of outcome we cannot fully observe based on conditions that
we can observe.
As long as the outcome, in this case product quality, can be observed, assur-
ance is achieved through observation or inspection. However, if the outcome
cannot be observed completely or always, then relying solely on observation or
inspection would not be effective. For that reason, there needs to be a way to
assure the reliability of the performance of the process in order to assure the
quality of the outcome. For the process to be reliable and predictable, the sys-
tems and equipment that support and perform the process must be reliable and
predictable. The systems and equipment must be fit for use and must perform in a
manner that will consistently result in the desired outcome. The desired outcome
is a process that results in a product of a specified quality and purity, a product
that is safe and effective.
Qualification confirms that systems operate in a manner that adequately sup-
ports the process. Qualification provides information and observable criteria,
including the design, installation, and operation of a system that supports a
process, which will be needed to predict the outcome of the process. A quality-
risk-based approach to qualification focuses efforts on those aspects and functions
that adversely affect product quality. There may be and there are sound reasons
to commission and qualify systems whose functions do not affect product qual-
ity. This chapter is not meant to dissuade those efforts. However, this chapter
focuses on the efforts required to qualify those functions and conditions affecting
product quality.
7.1.3 Role of Quality and the Quality Unit in Risk-Based Qualification
The ASTM E2500-07 Standard Guide states that the “ acceptance criteria of crit-
ical aspects ( that is, critical to product quality and patient safety ) should be
approved by the quality unit .” This is consistent with requirements and expecta-
tions of many regulatory agencies including the U.S. FDA. The FDA presents