ABSTRACT [QBD: A holistic concept of building quality in pharmaceuticals]

Quality by Design (QbD) refers to a holistic approach towards drug development. QbD has become the
answer to assist
both industry and FDA to move towards a more scientific, risk based, holistic and proactive approach to
pharmaceutical
development. The concept promotes industrys understanding of the product and manufacturing process
starting with product
development, basically building quality in, not testing it. Under this concept of QbD during designing and
development of a
product, a company needs to define desire product performance profile [Target product Profile (TPP),
Target Product Quality
Profile (TPQP)] and identify critical quality attributed (CQA). On the basis of the information company
then design the
product formulation and process to meet the product attributes. This leads to understand the impact of raw
materials [critical
material attributes (CMA)], critical process parameters (CPP) on the CQAs and identification and control
sources of
variability. As results of all understanding, a company can continually monitor and update its
manufacturing process to
assure consistent product quality. This systematic approach to product development and manufacturing
has received a great
deal from traditional approach, which was extremely empirical. Implementation of QbD is enabling
transformation of the
chemistry, manufacturing, and controls (CMC) review of Abbreviated New Drug Applications (ANDAs)
into a modern,
science and risk based pharmaceutical quality assessment.
Key words: Target Product Profile (TPP), Target Product Quality Profile (TPQP), Critical Quality
Attributes (CQA), Critical
Material Attributes (CMA), Critical Process Parameter (CPP), Design Space


ABSTRACT [Q8-Quality risk management]
[Q8]Risk management principles are effectively utilized in many areas of business and
government including finance, insurance, occupational safety, public health,
pharmacovigilance, and by agencies regulating these industries. I t includes scope, principlesof
quality risk management,general quality risk management process,responsibilities, I nitiating a
Quality Risk Management Process, Risk Assessment, Risk identification, Risk analysis, Risk
evaluation, Risk Control, Risk reduction, Risk acceptance, Risk Communication, Risk Review,
risk management methodology,integration ofquality risk management into industry regulatory
operations.