PROCESS DEVELOPMENT AND CLINICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 100

“Pharmaceutical quality assurance” means the total sum of the organized
arrangements made with the object of ensuring that medicinal products or
investigational medicinal products are of the quality required for their intended
use.
As the patient may not know how to precisely define his or her wants or
needs and because society as a whole requires that the patient be protected,
all pharmaceutical products intended for human use are controlled. In fact,
the ICH quality vision encompassed in July 2003 as a prelude to developing
the Q8, 9, and 10 trilogy of product and process life cycle guidance described
just such a system:
“The goal is to develop a harmonized pharmaceutical quality system applicable
across the lifecycle of the product emphasizing an integrated approach to
quality risk management and science.”
This concept is a natural continuation from the ICH Q6A [1] guidance,
which states:
The quality of drug substances and drug products is determined by their
design, development, in-process controls, GMP controls, process validation
and by specifications applied to them throughout development and manufac-
ture.
The goal is to ensure the quality of the product destined for a clinical trial
by identifying product characteristics—critical quality attributes (CQAs) [2] and
their critical process parameters (CPPs)—that need to be controlled to manage
variability in the manufacturing and quality control sampling and testing process.
Note: During development it is not usually possible to fully identify or define
critical as opposed to key attributes and parameters, so care should be taken
to set relevant specifications that are refined as knowledge is gained through
development and manufacture, that is, throughout the product life cycle. This
chapter uses the designations (C)PP and (C)QA to indicate that the criticality is
under ongoing investigation, verification, and refinement along with the control
strategy.
ICH Q10 [3] describes the tools or enablers of product realization as knowledge
management and risk management. Knowledge is the systematic translation of
scientifically collected data into useful instructions by analysis and drawing of