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Featured Articles Features ISPE’s APQ Program & Guides Advance Pharmaceutical Quality 1 January 2021 ISPE has announced the launch of its Advancing Pharmaceutical Quality (APQ) Program with the publication of the ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System, a guide dedicated to the topic of CAPA. This article describes how the APQ Program has been built and summarizes the... Features A New Pharmaceutical Equipment Exposure Measurement Database 1 January 2021 This article describes the Pharmaceutical Equipment Exposure Measurement Database (PEEM-DB), which was launched in July 2019 by the ISPE Japan Affiliate for its members. PEEM-DB is offered as a tool for rationally advancing optimal containment equipment settings by collecting exposure measurement... Features Creating Effective Standard Operating Procedures 1 January 2021 Personnel management is the most challenging variable in maintaining current Good Manufacturing Practice (cGMP) across the life cycle of drug manufacture, safety, and supply. A standard operating procedure (SOP) outlines agreed-upon instructions for personnel training and instructions for... Features Model-Informed Drug Development Addresses COVID-19 Challenges 1 January 2021 Drug developers know that the odds of anyone compound demonstrating safety and efficacy for a disease and its affected populations are low. How can drug developers improve these odds and increase the efficiency and effectiveness of drug development? One useful tool is model-informed drug... Technical Quality Risk Management to Address Product Impurities 1 January 2021 Recently, recalls of angiotensin receptor antagonists, particularly valsartan, and warning alerts about N-nitrosodimethylamine (NDMA) impurities in drug substances such as ranitidine and metformin have demonstrated the urgent need for manufacturers and regulators to control impurities throughout... Technical GMP Implementation of Online Water Bioburden Analyzers 1 January 2021 Online water bioburden analyzers (OWBAs) are analytical instruments providing real-time or near-real-time measurement of bioburden in purified water systems.Cundell, A., O. Gordon, N. Haycocks, et al. “Novel Concept for Online Water Bioburden Analysis: Key Considerations, Applications, and Business... Technical Cleaning Validation Program Maintenance in a Process Life-Cycle Model 1 January 2021 The process life-cycle model, as discussed in the US FDA guidance on process validation, is a significant change in how we view validation.US Food and Drug Administration. “Guidance for Industry. Process Validation: General Principles and Practices.” January 2011.... Features Industry Leaders: Focused on the Mission 3 November 2020 Joydeep Ganguly, who is currently Senior Vice President, Corporate Operations, at Gilead Sciences, Inc., places a premium on working for a mission-oriented company. “If you choose the right company with the right ethos and a deep, tangible commitment to the patients, the mission is not just... Features Vision Inspection Using Machine Learning/Artificial Intelligence 3 November 2020 Pharmaceutical companies rely on automated vision inspection (AVI) systems to help ensure product safety. Although these systems overcome challenges associated with manual inspection, they can be hindered by limitations in their programming—if the system is programmed to consider every variation in... Features 2019 ISPE Europe Biotechnology Conference: Industry Transformations 1 November 2020 As biopharmaceuticals have become a major part of the pharmaceutical industry, we have witnessed significant transformations in product development, strategy, technology, and operations. This ongoing transformational process was the main theme of the fourth annual ISPE Europe Biotechnology... Features Current State of Oligonucleotide Therapeutics 1 November 2020 Oligonucleotides are a relatively new class of drugs, composed of natural and synthetic nucleotides, which primarily include small interfering RNA (siRNA), micro RNA (miRNA), and antisense oligonucleotide (ASO). These molecules achieve therapeutic effects through RNA interference, degradation, or... Features Memorable Milestones: 40 Years of ISPE 1 November 2020 ISPE is celebrating its 40th anniversary this year! Here are some of the memorable events from the last 40 years. Features Flexible Facility Design for Multiple Cell Therapy Processes 1 November 2020 In many critical ways, the design of facilities for multiple cell therapy processes is unlike the design of conventional pharmaceutical facilities. This article surveys several of the key issues to consider when designing facilities capable of manufacturing multiple cell therapies, including... Features Operational Risk Management in Global Supply Scenarios 1 November 2020 The current regulatory framework in the pharmaceutical industry places pressure on marketing authorization holders (MAHs) to demonstrate quality oversight, and a systematic risk management process is a prerequisite for avoiding compliance and productivity pitfalls. This article focuses on options... Special Reports 2020 ISPE Annual Meeting & Expo: Driving the Future of Pharma 1 September 2020 The 2020 ISPE Annual Meeting & Expo will be ISPE’s first completely virtual Annual Meeting. As always, there will be great learning and networking opportunities—in fact, the digital format offers greater flexibility for attendees. Features Validation of Clinical Trial–Related Systems in Smaller Enterprises 1 September 2020 Existing risk-based approaches to computerized system compliance and validation as outlined in GAMP® 5International Society for Pharmaceutical Engineering. GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems. North Bethesda, MD: International Society for Pharmaceutical... Special Reports FOYA Category Winners & Honorable Mentions for 2020: Examples of Excellence 1 September 2020 Each year, ISPE celebrates innovations and advances in pharmaceutical manufacturing technology with its Facility of the Year...