ISPE created the Product Quality Lifecycle Implementation (PQLI)® initiative to provide guidance on the practical implementation of the concepts described in International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines which established enhanced, science- and risk-based approaches to product development, technology transfer, and manufacture. PQLI teams are formed with a specific problem statement and consist of experienced subject matter experts who work toward fulfilling their remit. The Q12 Implementation and Q13 Continuous Manufacturing working groups aim to further the implementation of ICH Q12 and continuous manufacturing within the industry and within international regulatory agencies by providing insight, information, and training. To that end, committee members have published numerous articles, delivered webinars, given conference presentations, and influenced ISPE Guidance Documents, including ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing of Oral Solid Dosage Forms released in October.
Since 2022, the ISPE Product Quality Lifecycle Implementation (PQLI)® Committee Q12 and Q13 team members have successfully organized and delivered five impactful training sessions on ICH guidelines to health authorities across multiple continents. This included the delivery of training on ICH Q12 implementation to four unique agencies: Health Canada and Brazil’s ANVISA in 2022, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) in 2023, and Singapore’s Health Sciences Authority (HSA) in 2024, with participation from the US Food and Drug Administration (US FDA) in the most recent two events. In 2025, the teams delivered training on ICH Q13 to Health Canada with participation from MHRA and HSA. Due to these efforts, more than 480 inspectors and reviewers have been trained by the two PQLI working groups globally.
PQLI’s training initiative first began when ISPE was asked by Health Canada to provide training with case studies to prepare Health Canada reviewers for applications with new tools/enablers under the eventual full implementation of Q12 in Canada. For the initial Q12 training and subsequent Q12 and Q13 training sessions, the PQLI members worked cooperatively with representatives from the health authorities to develop agendas tailored to their needs that complemented those produced by the ICH Working Groups.
The training they developed was delivered live, remotely and consisted of presentations, breakout sessions, and discussions held in four half-day sessions. For HSA, this required the PQLI members to present material late into the evening, with one member being online from 0000 to 0400 EST, demonstrating their commitment and dedication. These customized training sessions were technically robust and logistically complex, advancing ISPE’s mission to be the global industry leader in connecting pharmaceutical knowledge to deliver manufacturing and supply chain innovation, operational excellence, and regulatory insights to enhance industry efforts to develop, manufacture and reliably deliver quality medicines to patients.
Due to its success, the training developed by PQLI committee members is expanding ISPE’s global thought leadership within the pharmaceutical industry. The initial Q12 training led directly to Health Canada’s selection of ISPE to provide Q13 training, resulted in the recommendation of ISPE to other health authorities for Q12 training, and created additional inquiries from various health authorities for trainings on other ICH topics. Additionally, by contributing to the professional development of regulators and industry professionals worldwide, these PQLI working groups aim to provide solutions to complex pharmaceutical industry challenges through manufacturing innovation, member and workforce development, technical, regulatory, and compliance collaboration.
Learn more about the ISPE PQLI Committee Q12 and Q13 Teams and the other 2025 ISPE International Honor Awards winners. The 2026 ISPE Honor Awards winners will be recognized at the 2026 ISPE Annual Meeting & Expo, taking place 18-21 October 2026 in Washington, D.C., USA and virtually. Nominations will open in March.
The PQLI Committee is made up of ISPE members.
Learn more about PQLI
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