A Pharma Manufacturer's View of Quality by Design - Pharmaceutical Technology

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A Pharma Manufacturer's View of Quality by Design
Pfizer's Experience with QbD. This article is part of a special issue on Outsourcing.


Pharmaceutical Technology
Volume 35, pp. s34-s39

Pfizer and QbD

The Pharmaceutical cGMP Initiative emphasizes scientific collaboration between FDA, academic institutions, and industry organizations. Pfizer, for example, collaborated with the FDA's Manufacturing Sciences Working Group, which was established at the launch of the 21st Century Initiative to identify efficient approaches for characterizing and controlling critical manufacturing process parameters and quality assurance.

CRADAs . Also in conjunction with the Pharmaceutical cGMP Initiative, Pfizer established a cooperative research and development agreement (CRADA) with FDA to research chemical imaging applications in pharmaceutical manufacturing and quality assurance. Technologies resulting from such CRADA agreements are in the public domain and intended for usage industrywide.

CMC pilot . In 2005, Pfizer volunteered and was among 12 pharmaceutical companies selected to participate in FDA's CMC (Chemistry, Manufacturing, and Controls) pilot program under the auspices of FDA's Office of New Drug Quality Assessment. The pilot was conceived to develop guidance for a new approach and related system for pharmaceutical quality assessment (1). Participants submitted CMC and other control information demonstrative of their QbD approach, product knowledge, and process understanding of the drug substance and drug product in a new drug application (NDA) or supplemental NDA. Pfizer's NDA for Chantix (varenicline) was the first candidate in the pilot program to achieve FDA approval.

Organizational approaches to QbD . Today, QbD is part of the pharmaceutical industry's acronym-laden lexicon, as reflected by its prominence as a topic at trade association meetings, symposia, and the steady up-tick in QbD training and similar initiatives in place at Pfizer and other pharmaceutical companies. Recognizing the criticality of new quality paradigms in the development of future medicines, in 2006, Pfizer established an internal Quality by Design Limited Duration Team (QbD LDT). Charged with developing guidelines for the implementation of QbD throughout Pfizer, the team developed a Quality by Design Toolkit for roll out to codevelopment teams and sites. Conceived as a "living document," the QbD Toolkit provides Pfizer development and manufacturing organizations with a list of agreed-upon QbD definitions for use within Pfizer and in its regulatory submissions. Knowledge gains are incorporated as the company extends its application of QbD approaches, and results are evaluated. Updated regularly, the most current definitions are posted to the QbD section of Pfizer's intranet for easy access.

Also in 2006, Pfizer Global Research and Development (PGRD) created a Right First Time Program Office that provides structure and facilitation support to implement the risk- and science-based product and process codevelopment program. Part of the mission of the program office is to continually improve the effectiveness of risk- and science based approaches.

Picking up where the QbD LDT left off, in 2010, Pfizer established a Quality by Design Council (QbDC) to guide internal policy development and provide oversight and alignment of activities that influence QbD and related topics. This knowledge is inclusive of information gained from Wyeth in Pfizer's acquisition of the company as Wyeth had developed a department for executing QbD, and much of the institutional knowledge Wyeth had developed has been absorbed into Pfizer's current QbDC philosophy and positions. In addition to maintaining and updating the QbD Toolkit, the Council links with Pfizer employees who are engaged in QbD initiatives to maintain alignment with internal and external policies and to communicates QbD strategies, policies, and guidance to company employees at Pfizer Global Supply (PGS) and Worldwide Pharmaceutical Sciences (WWPS).

In 2007, when PGS and WWPS discreet Global Quality Operations (GQO) units were integrated to achieve "One Pfizer, One Quality System," they embarked on a collaborative process that exceeded industry standards for excellence in product codevelopment by building a strong foundation and developing a set of working processes to ensure effective product launch, supply, and life-cycle management. The interface between WWPS and PGS is the cornerstone of Pfizer's systematic and rigorous codevelopment process. Incorporating all the elements of QbD, Lean manufacturing, green chemistry, and other critical initiatives within Pfizer, codevelopment between PGS and WWPS uses a joint-governance and joint-procedures approach.


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