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Reshaping pharmaceutical quality

The first scientific papers outlining the progress made on the Product Quality Lifecycle Implementation (PQLI) initiative are being published in the June 2008 issue of the Journal of Pharmaceutical Innovation (JPI). Written by experts representing the global pharmaceutical manufacturing industry, these papers present practical scientific and technological approaches to implementing ICH* documents that address pharmaceutical development, quality risk management and pharmaceutical quality systems. The June issue will be published in print and is available free of charge on Springer's electronic information platform SpringerLink at with the possibility to comment.

The PQLI initiative was launched by the International Society for Pharmaceutical Engineering (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. PQLI is projected to be at least a five-year initiative that has started with interactive fact-gathering sessions held in the USA and Europe. For background information on the PQLI papers, please see

The criticality study 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 quality by design (QbD) principles. Design space discussions considered the linkage of the patient experience with product quality. 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. The Legacy Products Team has started work and will produce a paper later in 2008 in JPI.

"The task teams are to be congratulated for their technical publications in the Journal of Pharmaceutical Innovation which embrace input from interactive global workshops that included participation from both industry and regulators," said Moheb M. Nasr, Ph.D., Director, Office of New Drug Quality Assessment (CDER, FDA). "These papers, and the PQLI initiative, are important 'next steps' to facilitate the implementation of QbD and to answer the tangible challenges."

Jacques Morenas (AFSSAPS) and current chairman of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) said, "EU regulators are ready to work with ISPE on the future role of the EU Qualified Person, taking into account how critical it is. Work is already in progress as we can see from efforts made in conjunction with the Processed Analytical Technology (PAT) Team at the European Medicines Agency (EMEA) level and we will be happy to continue."


Contact: Joan Robinson

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