QUALITY BY DESIGN - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 96

quality. This clarity will enable activities to be prioritized and to concentrate on
what is most critical. Over time, this should lead to efficiency improvements, such
as more effective R&D processes, improved manufacturing process capability,
reduction in product and process failures, and enabling of cost-effective process
validation. And these will bring business benefits.
But, most importantly, QbD will help assure high quality products that patients
expect and deserve.
GLOSSARY AND DEFINITIONS
QbD : a systematic approach to development that begins with predefined objec-
tives and emphasizes product and process understanding and process con-
trol, based on sound science and quality risk management [1].
Quality attribute : a physical, chemical, or microbiological property or char-
acteristic that directly or indirectly relates to predefined product quality
(safety, identity, strength, purity, and marketability of the product).
CQA : a physical, chemical, biological or microbiological property or charac-
teristic that should be within an appropriate limit, range, or distribution to
ensure product quality [1].
Process parameter : a process variable (e.g., temperature, compression force)
that can be assigned values to be used as control levels or operating limits.
CPP : a process parameter whose variability has an impact on a critical quality
attribute and therefore should be monitored or controlled to ensure the
process produces desired quality [1].
Design space : the multidimensional combination and interaction of input
variables (e.g., material attributes) and process parameters that have been
demonstrated to provide assurance of quality [1].
Control strategy : a planned set of controls derived from current product
and process understanding that ensures process performance and prod-
uct quality. The controls can include parameters and attributes related to
drug substance and drug product materials and components, facility and
equipment-operating conditions, in-process controls, finished product speci-
fications, and the associated methods and frequency of monitoring or control
[1] and [3].
Life cycle : all phases in the life of a product from the initial development
through marketing until the product's discontinuation [1].
Quality target product profile : a prospective summary of the quality character-
istics of a drug product that ideally will be achieved to ensure the desired
quality, taking into account the safety and efficacy of the drug product [1].
Quality risk management : a systematic process for the assessment, control,
communication, and review of risks to the quality of the drug (medicinal)
product across the product life cycle [2].
Risk assessment : a systematic process of organizing information to support
a risk decision to be made within a risk management process. It consists