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Where are you now? Intelligence Services > 21 CFR Part 11 > 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 goal.

How can PAT succeed? We claim that PAT without appropriate prerequisites will be just another expensive pet project for a number of companies. Why?

  • 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 validations.
  • 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.

Bela Jancsik
Executive director
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