Where are you now? Regulatory Basis > 21 CFR Part 11 Issues > Compliant Products > Process Analytical Technology (PAT) > Process Analytical Technology (PAT)
Process Analytical Technology (PAT)
Is PAT your pet project?
GMP or CGMP? "C" is the variable parameter in the
evolutionary process of "Current Good Manufacturing Practice".
"C" can also stand for Capability factor in GMP. Is the pharmaceutical
industry capable of developing & producing quality products in an
economically meaningful process? Can the industry optimize knowledge, people
& technology to find the balance for best practices? Can the industry
satisfy consumers, investors, and regulators at the same time? How can science
help? If we could reduce the manufacturing cycle time, improve quality, &
reduce costs all at the same time, then we have met the challenge. Experts
believe that Process Analytical Technology (PAT) can be the solution toward this
How can PAT succeed? We claim that PAT without appropriate
prerequisites will be just another expensive pet project for a number of
- Claim 1: DQ is not understood. DQ must be
understood and made part of all User Requirement Specifications (this will
assist in analyzing critical quality requirements relative to
worst-case-scenario conditions). DQ is one the most important requirements
relative to PAT. In spite of this, DQ is the missing part in most system
- Claim 2: Not enough DQ tools & methods
are available. Tools must be provided for DQ. Because DQ is not recognized
as a critical component of DQ-IQ-OQ-PQ, few tools have been developed.
- Claim 3: DQ must be interconnected with PQ
(this will assist in the determination of the robustness of critical quality
parameters). Because DQ is poorly understood and PQ is poorly applied, this
requirement is difficult to meet.
- Claim 4: You cannot do it without properly
trained people. Competency management, the foundation for meaningful
training, is rarely utilized in the industry. A Competency Information
Management System must play the same role in Human Resource Management as
LIMS does in laboratory management.
- Claim 5: Task management should be
integrated into process management. You cannot understand the process
without the details of task attributes & task relationships.
- Claim 6: Quantitative planning is not
integrated into the requirements. DOE, multi-variate analysis, analysis of
measurement uncertainty, and chemometric tools & models must be
integrated into the above.
- Claim 7: Strategic products are not
developed. Newly developed application programs continue to ignore a
meaningful integration of 1-6. Most application programs are developed on
fast track and a good enough basis. Strategic considerations rarely form
part of requirements analysis.
- Claim 8: New technologies are not developed
any differently from the existing ones. All of the new technological
capabilities, such as NIR, ATR, acoustic devices, and others for
on-line/in-line measurements are not developed differently from Claim 7.
We will focus on the above issues and hope to find counterclaims
and counterexamples to the above propositions. We are also interested in your
comments, criticisms, and questions.