Biomedical Engineering Reference
In-Depth Information
3.2 Knowledge Management and Process Monitoring
in the QbD Paradigm
3.2.1 Knowledge Management
The role of quality control in traditional pharmaceutical manufacturing was lim-
ited to doing end product testing. Most such analysis was performed retrospec-
tively, after the product had already been manufactured, thus leaving the
manufacturer the choices of either accepting or rejecting a product lot. Lot
rejection results in an increase in the cost of manufacturing the product. In the
QbD/PAT paradigm, there is an emphasis of putting in place a more holistic
approach for determination of product quality and establishment of process control
to ensure consistent product quality.
While the need for efficient knowledge management in a complex and
knowledge-intensive industry such as the pharmaceutical industry was always
there, the need for efficiency and thereby the cost of inefficiency of managing
knowledge within a company have become critical in the QbD/PAT paradigm. At
present, knowledge transfer within companies is somewhat limited across the
different departments, namely clinical, commercial, quality and regulatory. A lot
of information is documented in the form of technical reports which may not even
be accessible outside the function that created them. Even if such reports are
accessible, raw data may not be easy to obtain. This is especially true if the author
of the technical report is no longer an employee of the company. It is clear that
companies that are successful in the future will be characterized by efficient
knowledge management networks that ensure that the right knowledge reaches the
right person at the right time.
The following are some salient points of knowledge management in the QbD
paradigm:
1. Companies are spending a lot more effort upfront to meet the higher expecta-
tions from QbD activities such as identification of CQA and of critical process
parameters (CPP). With the known complexity of pharmaceutical products,
budgetary and timeline constraints require a company to leverage knowledge
from multiple sources. These include:
(a) Prior experience in process and product development that the company has
in developing the product in the earlier stages of product development
(discovery, toxicity etc.).
(b) Prior experience in process and product development that the company may
have in developing similar kinds of products (monoclonal antibody,
globular protein etc.), the clinical indication and the mechanism of action
of the product.
(c) Published literature from other companies that may be working on similar
products and clinical indications
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