ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.
In 2023, the ISPE Commissioning and Qualification (C&Q) Community of Practice (CoP) conducted a survey on the adoption of integrated C&Q, focusing on the use of paperless/digital systems for planning, executing, and reporting C&Q activities. According to the survey, 74% of respondents anticipate using digital validation tools (DVTs) for C&Q by 2024. “Over the last five years,...
In the pharmaceutical industry, disaster recovery is not just about protecting business continuity; it is about safeguarding patient safety, data integrity, and the entire supply chain. The increasing complexity of global pharmaceutical operations exposes companies to a broad spectrum of risks, ranging from man-made disasters such as geopolitical conflicts to natural disasters that can cripple...
ISPE’s Q12 Implementation team, a working group under the auspices of ISPE's Product Quality Lifecycle Implementation (PQLI)® committee, continued their series of training events with a well-attended course delivered to Singapore’s Health Sciences Authority (HSA) in November 2024.
The ISPE Sterile Products Processing Community of Practice (CoP) Steering Committee continues its series of blog posts, where committee members and other contributing subject matter experts dive into the validation and use of essential equipment and processes that drive sterile processing in the pharmaceutical industry. The aim is to provide practical insights that will enhance your...
Per- and polyfluoroalkyl substances (PFAS) have emerged as a major concern in the pharmaceutical industry and beyond. Restricting their use is heavily debated. On the one hand, these “forever chemicals” can pose environmental and human health risks. On the other hand, their unique physical and chemical properties can make them important for pharma and ultimately for helping to enable access to...
Ronald Bauer, PhD and Christina Meissner, PhD from the Austrian Agency for Health and Food Safety (AGES) provided a much-anticipated presentation on the requirements for data management in light of the revised Annex 1 at the 2024 ISPE Pharma 4.0™ and Annex 1 Conference in Rome, Italy in December 2024.
In today’s rapidly evolving pharmaceutical landscape, advancing technologies, shifting regulatory landscapes, and emerging global challenges such as supply chain disruptions, and drug shortages have significantly impacted how we develop, manufacture, and deliver treatments. These factors underscore the critical need for robust validation approaches for computerized systems to safeguard patient...
The US pharmaceutical manufacturing sector is preparing for continued, significant growth over the next decade, fueled by robust investments and evolving market demands. At the same time, this growth presents significant challenges—chief among them, the imperative to attract and retain a highly skilled workforce and to integrate advanced technologies that streamline operations and boost...
In the pharmaceutical industry, expertise is essential—but connection is what turns expertise into impact. No single professional, company, or discipline holds all the answers to the challenges we face. Progress happens when experts come together, share knowledge, and build upon one another’s insights. That’s exactly what ISPE enables: a global network of professionals who not only advance...
The pharmaceutical industry is undergoing a significant transformation, moving away from traditional paper-based validation processes to adopt digital validation tools (DVTs). This transition began with electronic validation repositories, enabling the digital creation, uploading, and electronic approval of documentation—securely stored and meeting electronic records and signatures compliance...
The future of the pharmaceutical industry is being shaped by rapid advancements in digital technologies, automation, and data analytics. As we look ahead to 2025, the concept of Pharma 4.0™ is no longer just an aspirational vision—it is becoming a transformative reality that will redefine how medicines are developed, manufactured, and delivered to patients.
Lindsey Daniel, Director of Product Operations Strategy and Business Lead at Takeda, is an exemplary champion for and beneficiary of ISPE. Daniel embodies leadership and collaboration in numerous ways: as a mentor, mentee, friend, colleague, mother, and more. With over 12 years of active involvement with ISPE, she has served on various committees, including ISPE’s International Women in...
In the pharmaceutical industry, ensuring the safety, quality, and efficacy of products is paramount. With the increasing complexity of manufacturing processes, the growing reliance on computerized systems and advancements in technology, GAMP® guidance provides a framework for validating and maintaining the integrity of computerized systems, ensuring they are fit for their intended...
The presentation by Ian Deveau, PhD, from the US Food and Drug Administration (US FDA) Office of Compounding Quality and Compliance at the 2024 ISPE Annual Meeting & Expo on 15 October 2024 provided an in-depth look at the US FDA’s perspective on drug compounding, its regulatory framework, and the significant events that have shaped current practices. Here is a summary of the key points...
Every dose of medicine represents a promise of quality—a commitment to safety, efficacy, and availability for the patients who depend on it. At the 2024 ISPE Annual Meeting & Expo, Jennifer Maguire, PhD, Director of the US Food and Drug Administration’s (US FDA) Office of Quality Surveillance (OQS), outlined how the agency is transforming its approach to pharmaceutical quality surveillance...
