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Reshaping Pharmaceutical Quality

Published: Tuesday, June 10, 2008 - 21:00

(ISPE: Tampa, Florida) -- The June 2008 issue of the Journal of Pharmaceutical Innovation (JPI) is publishing the first scientific papers outlining the progress made on the International Society for Pharmaceutical Engineering’s (ISPE) product quality life cycle implementation (PQLI) initiative. Written by experts representing the global pharmaceutical manufacturing industry, the papers present preliminary practical scientific and technological approaches to implementing International Conference on Harmonization (ICH) documents that address Pharmaceutical Development (Q8 and Q8[R]), Quality Risk Management (Q9), and Pharmaceutical Quality Systems (Q10). The June issue will be published in print and with open access on SpringerLink with the possibility to comment.

The PQLI initiative was launched by ISPE in June 2007 to help industry find practical technical solutions to the challenges of implementing guidelines put forth by the ICH. The first three task teams formed focused on criticality, design space, and control strategy, and how these areas are linked; a legacy products task team has also been formed as the fourth topical area.

Through PQLI, ISPE is providing technical frameworks to facilitate the implementation of Q8, Q9, and the imminent Q10 for new products and processes, as well as for existing approved products that could benefit. PQLI will provide better understanding of quality by design (QbD) applied to new products and processes, and is developing cross-functional tools valued by the industry and regulatory authorities worldwide. While the output is critical for industry application, the conclusions have been reached with input from global regulators. With the publication of these articles, the ISPE PQLI task teams are seeking additional feedback prior to developing their respective positions into technical documents. 

PQLI is projected to be at least a five-year initiative that has started with highly interactive fact-gathering sessions held in the United States and Europe. Working groups will continue to collect and process information for distribution as white papers, articles to be published in ISPE’s Journal of Pharmaceutical Innovation and Pharmaceutical Engineering Magazine, leading to detailed technical documents and training programs that will be produced by ISPE for the industry worldwide.

“The ISPE PQLI task teams are to be congratulated for their technical publications in JPI on criticality, design space, and control strategy, which embrace inputs from open, interactive global workshops that included participation from both industry and regulators,” says Moheb M. Nasr, Ph.D., director of the Food and Drug Administration’s office of new drug quality assessment.

“These papers, and the PQLI initiative, are important next steps to facilitate the implementation of QbD and to answer the tangible challenges.

“EU regulators are ready to work with ISPE on this topic taking into account it is a critical point. Work is already on progress as we can see with work made into PAT team at the EMEA level and we will be happy to continue,” says Jacques Morenas, current chairman of the pharmaceutical inspection cooperation scheme, referring to the importance of understanding the future role of the EU qualified person within the frameworks of ICH Q8, Q9, and Q10.

The criticality article describes a mechanism for categorizing and delineating criticality for quality attributes, variables, material attributes, and process parameters in accordance with a risk-based approach reflective of QbD principles articulated in ICH Q8R. The article introduces the adoption of a criticality analysis decision tree to categorize criticality relative to a variable’s effect to quality and delineate levels of criticality with respect to relative risk.

Design space discussions considered the linkage of the patient experience with product quality. It also focused on how risk-assessment methodologies integrate with process design principles, provided perspective on selection of mechanistic vs. empirical approaches, and clarified how they may be applied to legacy products, and biotech products. The team also discussed a number of useful methods for depicting design space. The team recognizes that organizations may choose different, scientifically defensible means to arrive at design space. 

The control strategy team has proposed a model process to enable a clear logic to be used on how a control strategy differentiates between patient and business requirements, as well as showing the linkage from critical quality attributes, e.g. via critical process parameters, to individual controls such as analytical, process analytical technology (PAT), engineering, procedural, or other controls. The model illustrates how the control strategy embraces ICH requirements (product and systems). It will also provide a discussion bridge between disciplines such as development scientists and controls engineers.

The legacy products team has started work and will produce a paper later in 2008 in JPI. The team is considering how to derive business benefits by reviewing knowledge about a product and/or process and proposing opportunities for flexibility in a post approval regulatory application for an approved product. A suggested workflow process will be produced and supported by case studies.

“The publication of these papers is a milestone event as it will bring together an industry view of a risk and science based design approach for pharmaceuticals,” says James C. Spavins, vice president of global CMC at Pfizer. “The use of risk-based analyses to determine design constraints and then determine appropriate controls is a foundational process for the advancement of science and technology—it is time for pharmaceutical professionals to have an aligned view.”

For more information, visit www.springer.com/biomed/pharmaceutical+science/journal/12247


About The Author

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The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association of 22,000 pharmaceutical professionals in 90 countries who use knowledge to create high-quality, cost-effective good manufacturing practices (GMP) solutions. ISPE provides its members opportunities to develop technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning for a global audience. Its world headquarters are in Tampa, Florida, with offices in Brussels, Belgium, Shanghai, China, and Singapore.