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Due to the growing digitalization of the industry, we are highly dependent on information technology (IT) systems and data. The basic ability to execute our pharmaceutical business and decision-making processes relies on the permanent availability of these IT systems and data to ensure compliance and efficiency of our business operations. But numerous factors—including criminal activities,...

Features

IT infrastructure has traditionally been provisioned using a combination of scripts and manual processes. This manual approach was slow and introduced the risk of human error, resulting in inconsistency between environments or even leaving the infrastructure in an unqualified state. In this article, we investigate some fundamental advantages of using Infrastructure as Code (IaC) for...

Features

This article provides a brief introduction into the standards and regulations for medical devices. It compares the ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) and applicable ISPE GAMP Good Practice Guides against the relevant regulations and standards for the development of software for medical devices and demonstrates GAMP® 5 Second...

Technical

The biotechnology and pharmaceutical sectors have pledged to reduce greenhouse gas (GHG) emissions as the climate concerns of consumers, investors, and regulators continue to grow. In seeking to benefit from this demand for sustainability and the potential for cost-saving opportunities, life science product manufacturers have started to evaluate the climate impact of their own labs and...

Technical

Calibration plays a critical role in ensuring a measurement instrument’s accuracy—especially if the instrument has a direct impact on product quality and patient safety. However, the calibration process is a complex system, and the traditional analytical approach for planning this process is often not sufficient to improve service performance. Using a digital simulation model as a...

Technical

Cell therapies have been used to treat thousands of patients worldwide ever since the CAR T cell medication Kymriah was the first cell therapy approved by the FDA in 2017.  Yet significant manufacturing challenges continue to hamper patient access to life-saving cell therapies, particularly the high cost of these treatments. Kymriah can cost as much as $475,000 per dose and an allogeneic...

InTouch

An ISPE member since 1999, Charlie Wakeham has been active within the ISPE GAMP® community since 2001. A founding member of the GAMP UK Community of Practice (CoP), she is currently Chair of the GAMP Global CoP Steering Committee, one of the leaders of the GAMP Computer Software Assurance Special Interest Group (SIG), and a member of the ISPE Guidance Documents Committee. She has co-led or...

InTouch

Lorrie Vuolo-Schuessler has been involved with ISPE and GAMP® projects since 2002. She has authored or co-led 11 ISPE GAMP-focused guidance documents, including ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) and the ISPE GAMP® Good Practice Guide: Enabling Innovation - Critical Thinking, Agile, IT Service Management. She is Immediate Past Chair of...

Features

Advanced therapy medicinal products (ATMPs) are one of the most promising developments in the pharmaceutical and biotech industries in recent decades. Although there is a great promise to treat and even cure many diseases with these products, there are also unique challenges, especially with their supply chains.

Features

Facility design decisions made early in conceptual design can have a significant impact on the cost of goods sold (COGS) in the manufacture of autologous and allogeneic cell therapy products. Understanding the impact of a COGS analysis is an important aspect of the early-phase design process.

Features

Live biotherapeutic products (LBPs) have the potential to treat a wide range of ailments. However, these living microorganisms are difficult to produce due to evolving government regulations and limited GMP manufacturing experience. New facility designs and more specific process guidance could help overcome these challenges. This article explores the nuances of facility design and regulatory...

Features

Cell and gene therapy (C&GT) products comprise a rapidly growing field of innovative medicines that hold the promise to treat and, in some cases, cure diseases that are otherwise untreatable. In this article, we provide points to consider when evaluating the comparability of C&GT when changes are made in their manufacturing processes.

Features

As the demand for accelerated access to medicines expands globally, the pharmaceutical industry is increasingly submitting regulatory applications in multiple countries simultaneously. As a result, Boards of Health (BoHs) are challenged with approving these applications in an accelerated timeframe and accommodating the submission of postapproval chemistry, manufacturing, and controls (CMC)...

Features

The new European Commission GMP Annex 1 “Manufacture of Sterile Medicinal Products” and the equivalent Annex 2 from the World Health Organization (WHO) triggered a discussion in ISPE’s Germany/Austria/Switzerland (D/A/CH) Aseptic Processing Community of Practice (CoP) Steering Committee about where to qualify air speed: “at working position” versus “at working level.” This article provides...

Features

The biopharmaceutical industry must develop and implement innovative ways of working to be effective and efficient in the current healthcare ecosystem, in which high-quality medicines, adaptability, and assurance of supply are of critical importance. There are regulatory strategies and technologies emerging to address these challenges, but further progress must be made to fully harness the...

Features

This article describes how ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) and related GAMP Good Practice Guides can be effectively applied to help meet the requirements of the proposed European Union (EU) artificial intelligence (AI) regulation for qualifying GxP-regulated systems employing AI and machine learning (ML).

Features

ISPE has launched an important new initiative, “Enabling Global Pharma Innovation: Delivering for Patients,” in support of the aspirations of many regulatory agencies globally to promote introduction of innovative pharmaceutical manufacturing.

Features

The creation of a new ICH guidance document, Q13,1

  • 1International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised Tripartite Guideline Q13: Continuous Manufacturing of Drug Substances and Drug Products.” Published July 2021.
Features

Understanding and managing risks to continuous manufacturing (CM) technology is central to any decision to greenlight CM in a production-ready environment. Applying a systemwide risk management (SRM) approach to manufacturing is essential to ensuring manufacturing projects are vetted in a comprehensive and consistent manner.

Features

Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification technology, with investment expected to rise in the coming years and the focus shifting toward biologics. This article provides a review on the current state of CM implementation, offers insights into life cycle management and regulatory aspects, and explains how a data- and knowledge-centric approach...

Features

In the interest of understanding the current state of continuous manufacturing for biologics and to facilitate the path toward adoption of these promising technologies, the United States Pharmacopeia (USP) and BioPhorum jointly sponsored a hybrid workshop. This article summarizes trends from the workshop and ponders next steps.

Features

When working with the common technical dossier (CTD), the structure of Module 2 “follows the scope and outline of the Body of Data in Module 3,”1

  • 1International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published 15 November 2021.
Features

The global pandemic has demonstrated that now, more than ever, we need to work toward a global solution and prioritize the harmonization of technical requirements. Positive improvements have been observed in the acceptance and implementation of international standards by various regulatory agencies in Latin America. This article offers an overview of the chemistry, manufacturing, and controls...

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Latest Articles

iSpeak Blog

Sustainability is emerging as a pivotal force influencing the pharmaceutical industry’s dynamics and steering companies towards transformative change. The focus of this analysis is to delve into the sustainability key performance indicators (KPIs) of prominent pharmaceutical players, namely Pfizer, Sanofi, Glaxo Smith Kline (GSK), Becton Dickinson, Johnson & Johnson, Abbott, Eli Lilly, and...

iSpeak Blog

ISPE’s Women in Pharma® community prides itself on endorsing equal opportunity for equal effort. Through global and regional programming, the community creates opportunities to shift company cultures and mindsets to create a more inclusive and equitable industry, where diversity of thought thrives.

iSpeak Blog

In 2020, CSL Behring (CSL) initiated a benchmarking activity with a small group of peer companies identified through ISPE and the members of the ISPE Supply Chain, Operations, and Packaging (SCOPE) Community of Practice (CoP) Steering Committee to explore creation and maturation of Asset Management programs at each company. The initial sessions were a success, covering topics such as Asset...

InTouch

In a prerecorded interview shown during a keynote session at the 2023 ISPE Annual Meeting & Expo, Tom Hartman, ISPE President and CEO, and Dr. Robert M. Califf discussed several far-ranging and important topics. Califf, the US Food and Drug Administration (FDA) 25th Commissioner is a recognized expert in cardiovascular medicine, health outcomes research,...

iSpeak Blog

The 2024 ISPE Facilities of the Future Conference brings more than 130 years of experience and insights from the six keynote speakers alone. GSK’s Carlos Santiago and Genentech’s Christian Randecker provided preliminary insights into what Facility/Factory and Workforce of the Future means to them as well as their greatest successes and challenges as they prepare their teams for that future....

InTouch

On 19 October, the ISPE Foundation hosted its 2nd Annual Golf Tournament at Wildhorse Golf Course following this year’s Annual Meeting & Expo in Las Vegas.

InTouch

The new ISPE Good Practice Guide: Process Gases, Second Edition presents recent advances in construction materials and updates on current good practices. It was revised based on the latest International Organization for Standardization in Pharmaceuticals, American Society for Testing and Materials, and American Society of Mechanical Engineers standards and is aligned with the latest regulatory...

iSpeak Blog

The ISPE International Honor Awards program serves as a platform to celebrate the dedication and excellence of our members and their contributions to the pharmaceutical industry. The prestigious 2023 ISPE International Honor Award for Committee of the Year recognizes the remarkable achievements of ISPE's committees, councils, task teams, or communities of practice steering committees.

iSpeak Blog

In the wake of the COVID-19 pandemic, the landscape of cell and gene therapy (CGT) manufacturing has witnessed significant transformation. The industry has seen an increased emphasis on the advantages of advanced therapy medicinal products (ATMPs) and the push for increases in manufacturing scale and overall availability to larger populations. ATMPs find themselves at a critical juncture where...

iSpeak Blog

What is the Route to Successful ATMP Cleanroom Development?

Mitch Gonzales, Vice President of Process Technology and Grant Merrill, Chief Commercial Officer at AES Clean Technology, explore the unique aseptic processing needs of advanced therapy medicinal products (ATMPs) and explain the ideal pathway to successful cleanroom design for this class of therapies.

iSpeak Blog

The ISPE Facility of the Future Conferences can feel like a crystal ball looking into the future . Year after year, speakers have presented what the future of the industry may look like, and then, in subsequent years, speakers will present how they have implemented that future. It is remarkable to see the future come to fruition and learn how others are navigating it. One of the greatest...

Current Issue

January / February 2024

Machine Learning Risk and Control Framework Cover: Stakeholders across industries are becoming accustomed to using information technology (IT) systems, applications, and business solutions that feature artificial intelligence (AI) and machine learning (ML). Even though some of these uses show phenomenal performance, thorough risk management is required to ensure quality and regulatory compliance...