(NORTH BETHESDA, MARYLAND, USA, 17 OCTOBER 2022) – The International Society for Pharmaceutical Engineering (ISPE) announced the release of the ISPE APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS). This Guide provides a quality management framework for assessing and advancing an organization’s PPPQMS maturity level by evaluating the following aspects:
Establishing a Control Strategy
Determining Tools for Measurement and Analysis of Parameters and Attributes
Analyzing Parameters and Attributes
Identifying Sources of Variation
Including Feedback on Product Quality from Internal and External Sources
Providing Knowledge to Enhance Process Understanding
“A PPPQMS is an element of the Pharmaceutical Quality System and is required for monitoring, analyzing, controlling, and improving the process performance and product quality. But what defines that system and what tools are available to support are not always fully understood,” said Guide Co-Lead Line Lundsberg, PhD, Lundsberg Consulting Ltd. “If you are on a digitization journey, this Guide is essential as it will help you by explaining the different PPPQMS elements. It also offers tools to assess your current maturity level and define the aspiration goals for an optimized system that is needed for a digital and automated monitoring and control system.”
ICH Q10 establishes an expectation for pharmaceutical companies to “plan and execute a system for the monitoring of process performance and product quality to ensure a state of control is maintained.” In addition to maintaining a state of control, an effective Process Performance and Product Quality Monitoring System (PPPQMS) enables continual improvement and proactively identifies the need for product quality and process improvements.
“If pharmaceutical companies do not have a system in place for monitoring process performance and product quality according to ICH Q10, they are not in regulatory compliance. The Guide describes Level 3 ‘Managed’ in the APQ 5-Level Maturity Model as meeting the expectations of ICH Q10 – this level is recommended as a prerequisite for starting the digitalization journey. Digitalization is the key to advancing the maturity of the Quality Management System from ‘Managed’ to the ‘Improved’ Level 4 and finally to the ‘Optimized’ Level 5,” said Christian Wölbeling, Executive Industry Advisor, Körber Pharma Software.
The Guide is the fourth publication in the APQ Guide series that seeks to improve the state of pharmaceutical quality and ensure sustainable compliance. The Guide Series is part of ISPE’s initiative, Advancing Pharmaceutical Quality (APQ), a comprehensive program for assessing and improving an organization’s quality management maturity. The program is aligned with international initiatives that promote quality excellence, as well as with the FDA’s interest in quality management maturity.
Purchase the ISPE APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS), the latest among ISPE’s many educational resources, online at ISPE.org/Publications/Guidance-Documents.
The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest nonprofit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 20,000+ members of ISPE provide solutions to complex pharmaceutical industry challenges through innovation, member and workforce development, technical, regulatory and compliance collaborations in more than 90 countries worldwide. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit ISPE.org for more information.
The International Society for Pharmaceutical Engineering (ISPE) today announced the 2022 Facility of the Year Awards (FOYA) Category Winners at the 2022 ISPE Europe Annual Conference in Madrid, Spain.
Category Winners Include:
The FOYA judges’ panel has also awarded Honorable Mention to:
Iovance Biotherapeutics, Inc.
FOYA is the premier global awards program recognizing innovation and creativity in manufacturing facilities serving the pharmaceutical industry. The award-winning projects selected by the FOYA program set the standard for pharmaceutical facilities of the future by demonstrating excellence in facility design, construction, and operations.
“The future of the pharmaceutical industry is being shaped every day by innovative companies worldwide. Companies like the 2022 FOYA Category Winners have a clear commitment to excellence and set the high bar for quality in the design and social impact consideration of their facilities," said Thomas Hartman, President & CEO, ISPE. “They incorporate a thoughtful, unique, and adaptive approach to innovation, operability, sustainability, and reliability while introducing flexibility allowing for the manufacturing of multiple product modalities. Further, these modern facility designs introduce digitization strategies that accelerate timelines from product development to product licensure. ISPE is proud to recognize these companies.”
The Innovation Category was awarded to CRISPR Therapeutics for its facility in Framingham, Massachusetts, USA. CRISPR Therapeutics has harnessed the CRISPR/ Cas9 gene-editing platform to develop and deliver potentially curative therapies to patients with serious diseases. The technology has game-changing implications for patients and partners. The project was awarded a FOYA award for Innovation based on the innovative design of the facility, which provides an end-to-end solution for production and fills operations. The FOYA judging committee commends CRISPR for creating a flexible, digitally enabled facility that can bring the promise of innovation to life.
Janssen Biologics, BV won the Project Execution Category for its Vaccine Launch Facility (VLF) Expansion in Leiden, The Netherlands. This Johnson & Johnson (J&J) biopharmaceutical production and laboratory testing facility produces clinical and commercial bulk active pharmaceutical ingredients and provides analytical testing services for J&J’s global portfolio of vaccines. The existing VLF represented an opportunity to enable large-scale COVID-19 vaccine drug substance manufacturing by building a new, 25,000 square-foot sterile manufacturing facility adjacent to the existing VLF. This fast-tracked project was developed to design and build the new facility within nine months and to secure regulatory approval for initial commercial batches produced in the facility within 12 months. The ambitious timeframe required a Herculean effort and flawless collaboration on the part of all involved parties, including best-in-class design and construction partners and an integrated, cross-functional team within J&J.
Takeda Pharmaceuticals International AG won the Supply Chain Category for its Alofisel Global Program in Madrid, Spain; Grange Castle, Ireland; Osaka, Japan; and California, USA. Alofisel is a first-in-class stem cell therapy product and the first allogeneic mesenchymal stem cell therapy to receive approval by the European Medicines Agency. The project was designed with a product shelf life of only 48 hours and requires seamless cold chain transportation. Takeda had to completely rethink the supply chain to get the product from the plant to the hospital to be administered to the patient within a very short time frame. The program is recognized in this year’s awards for its novel and innovative approach to end-to-end supply chain management as well as the program’s innovative design in expanding the Alofisel manufacturing network from its initial plant in Madrid, Spain, to other regions across the globe with new facilities in the US, Japan, and Ireland.
The Pharma 4.0 ™ Category was awarded to Takeda Pharmaceuticals International AG in Singen, Germany for its TaSiVa project. The TaSiVa facility took an innovative approach to the project of implementing pharma 4.0 technologies as part of the overall project delivery, which also complemented the companywide digital transformation. It included several key collaborations with suppliers and academia to develop pharma 4.0 solutions. The facility was built with state-of-the-art process equipment and then layered with advanced digital technologies in several key areas. A complete IT infrastructure upgrade was completed at the site during the early phase of the project thus providing the platform to utilize advanced information technology (IT)/ operational technology (OT) solutions as part of the project delivery. The project exemplifies how the application of innovation in advanced digital technologies leads to improved outcomes in terms of safety, product quality, and productivity in a pharmaceutical manufacturing facility.
The first of two companies to be awarded in the Social Impact Category is Catalent for its Project Mercury in Bloomington, Indiana. Catalent’s Project Mercury was delivered in the face of the global pandemic. With an unknown manufacturing process for a vaccine candidate under development, the team pivoted on existing projects to ensure success, adding 40% more scope including secondary packaging and inspection. The project added 40,000 sq ft to cover the most stringent of the unknown needs of the process, reducing the risk to supply. The project team also cut six months off their schedule and beat the clock while managing the complexities of execution within the COVID-19 restricted environment and delivering the needed capacity to meet important pandemic demands. They applied a great amount of effort and budget into adding additional safety measures to keep workers safe throughout the constant threat of the COVID-19 virus along with including three major elements of sustainability into their plans for Project Mercury: People, Planet, and Profits.
The second of two companies to be awarded in the Social Impact Category is Janssen Biologics, BV for its Vaccine Launch Facility (VLF) Expansion in Leiden, The Netherlands. During the VLF expansion construction activities were executed during an increased level of positive COVID cases in The Netherlands. J&J kept the personal safety of all project team members as its top priority by implementing various safety measures to reduce the risk of exposure to the COVID virus. These additional safety measures resulted in no significant stoppages or slowdowns of work during construction.
Iovance Biotherapeutics, Inc. was awarded an Honorable Mention for its Iovance Cell Therapy Center (iCTC) in Philadelphia, Pennsylvania. With only one chance of success and Iovance having a production timeline of 22 days, there is no room for error when developing therapies. Their facility was designed with significant redundancies to support its operation 24 hours a day, 365 days of the year. Iovance had a goal to “be the first company in the world to commercially produce a personalized therapy for solid tumors” and as a relatively small company, their achievement in that first, as well as having an excellent facility was recognized by the judges.
The 2022 FOYA Category Winners will be formally recognized at the ISPE Facility of the Year Awards Banquet, held in conjunction with the 2022 ISPE Annual Meeting & Expo, taking place 30 October–2 November 2022. The banquet will feature acceptance speeches from the FOYA recipients and presentations from noted industry leaders. The 2022 FOYA Overall Winner will be announced at the conference during the ISPE Membership Meeting and Awards Lunch on 1 November 2022.
Established in 2005, The Facility of the Year Awards (FOYA) recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operation while sharing the development of new applications of technology and cutting-edge approaches. Visit ISPE.org/FOYA for more information.
The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancements across the entire pharmaceutical lifecycle. The 20,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit ISPE.org for more information.
The Guide Series is part of ISPE’s initiative, Advancing Pharmaceutical Quality (APQ), a comprehensive program for assessing and improving an organization’s quality management maturity. The Guide was developed by members of the APQ Program which evolved from the ISPE Quality Metrics Initiative, representing extensive industry engagement, collaboration with academia and other associations, and knowledge sharing with regulatory agencies.
ICH Q10 sets a clear expectation regarding the role of strong leadership in terms of demonstrating and communicating “strong and visible support for the pharmaceutical quality system.” The ISPE APQ Guide: Management Responsibilities and Management Review provides a systematic and proactive approach to evaluating the management responsibilities highlighted in ICH Q10 as well as other key leadership components:
Patient/Consumer Focus
Management Commitment
Quality Planning
Internal Communication
Management of Outsourced Activities and Purchased Materials
Management of Change in Product Ownership
Regulatory and Industry Awareness
“This Guide provides a practical tool for organizations that want to assess and strengthen their leadership systems to support their pursuit of cultural excellence and ultimately create more value for their patients, shareholders, and employees,” said Guide Co-Lead Steven A. Greer, Executive Coach, Speaker and Consultant, Genesis Assist, LLC and ESi, Inc.
“Most scorecards do not include metrics focused on leadership effectiveness so drift can occur without warning signs and the results can be significant: drug shortages, enforcement actions, recalls, dissatisfied patients/consumers, and disengaged organizations. The APQ MRR Guide builds upon the framework of ICH Q10 with insights from industry leaders on what strong and effective leadership looks like,” said Guide Co-Lead Michael Grischeau, Director of Data Analytics and Management Review, AbbVie Inc.
The International Society for Pharmaceutical Engineering (ISPE) is a not-for-profit association serving its Members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,000 Members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland, USA, and its operations center in Tampa, Florida, USA. Visit ISPE.org for more information.