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

Several colleague teams were created around the WWPS/ PGS quality integration, among them the Global Biologics Quality Team. The key quality requirements for the manufacture of new biotechnology products at PGS sites that this team defines enable rapid transfer of manufacturing by WWPS. Committed to ensuring seamless transfers from WWPS into PGS bioprocessing facilities, the Global Biologics Quality Team is actively supporting manufacturing expansion projects at Pfizer sites in Europe and the United States. By working collaboratively between sites, leveraging best practices, capturing lessons learned, and shaping a life-cycle approach to regulatory compliance, the Global Biologics Quality Team and other teams formed around quality integration support Pfizer's industry standing and extend its biotherapeutics expertise.

Other notable accomplishments of this WWPS/PGS quality collaboration include:

  • Formation of cross-functional groups across areas and issues, including new-product molecules, biologics, and quality and regulatory policy.
  • Formation of cross-functional GQO teams to enhance relationships between PGS and WWPS quality operation units.
  • Creation of a cross-functional CQO team focused on identifying and advancing cross-functional life-cycle development opportunities.
  • Development, in partnership with Pfizer's Worldwide Regulatory Affairs (WRA), of a global submission-ready approach across the product life cycle to improve overall efficiencies and reduce cycle time. This work complements WRA's focus on regulatory subteams and M-4 Change Control (a value-stream assessment based on Lean principles) efforts within PGS.
  • Fostered a new model for a single contact CMC point of integration and formed CMC teams/subteams to optimize product life-cycle support efficiency.
  • Instituted Regulatory Strategy Documents for transparency of risk management with Pfizer's customers.
  • Established a One Voice for Quality and Regulatory Policy (QRP) process and rolled out the QRP newsletter to communicate QRP strategies to Pfizer employees.

Also notable, a Pfizer team met with FDA in September 2010 in anticipation of regulatory submission for a continuous manufacturing process. Continuous processing enables PGS to significantly lower production costs for active pharmaceutical ingredients and drug products while achieving highly reliable process and consistent product quality.

Another focus of Pfizer's QbD Council is the work of the International Conference on Harmonization (ICH). Closely aligned with many of the high level concepts found in ICH guidelines Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality Systems, QbD is a beneficial for the pharmaceutical industry, regulators, and patients (2–4).


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