Risk Management for Avoidance of Drug Shortages
Risk Management for Avoidance of Drug Shortages
Features
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Shortages of essential medicines around the world have been an ongoing concern for patients, caregivers, and regulators and have been exacerbated by the COVID-19 pandemic. Many regulators have instituted requirements for reporting potential or actual drug shortages.1  To further minimize drug shortages, regulators in the United States and France...

Featured Articles

An Evaluation of Postapproval CMC Change Timelines
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An Evaluation of Postapproval CMC Change Timelines

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)...

Air Speed Qualification: At Working Position or Working Level?
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Air Speed Qualification: At Working Position or Working Level?

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...

Considerations for a Decentralized Manufacturing Paradigm
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Considerations for a Decentralized Manufacturing Paradigm

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...

New EU AI Regulation and Gamp® 5
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New EU AI Regulation and GAMP® 5

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).

Enabling Global Pharma Innovation: Delivering for Patients
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Enabling Global Pharma Innovation: Delivering for Patients

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.

Industry Panel On Annex 1 Implementation Strategies
InTouch
Industry Panel On Annex 1 Implementation Strategies

Annex 1, the European Union’s revised GMP requirements for the manufacturing of sterile medicinal products, will take effect on 25 August 2023. In this panel, experts involved in industry’s commenting of the draft versions of Annex 1 offered background information on how the document was developed and answered questions on its implementation.

CoP Leader Profiles: Hubertus Rehbaum
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CoP Leader Profiles: Hubertus Rehbaum

Hubertus Rehbaum, PhD, is Chair of the Process Analytical Technology & Lifecycle Control Strategy (PAT-LCS) Community of Practice (CoP) Steering Committee. He’s been a member of ISPE for eight years. He first became involved through the Germany/Austria/Switzerland (D/A/CH) Affiliate when he joined as an Emerging Leader and helped co-host events for the group, which he said helped him...

CoP Leader Profiles: Catherine Hall
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CoP Leader Profiles: Catherine Hall

Catherine Hall is Chair of the Investigational Products, North America (IPNA) Community of Practice (CoP) Steering Committee and is one of the authors of the ISPE Good Practice Guide: Investigational Medicinal Product Reverse Logistics – Good Returns and Reconciliation Practices. She has been a member of ISPE for 18 years.

ICH Q13 and What Is Next for Continuous Manufacturing
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ICH Q13 and What Is Next for Continuous Manufacturing

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.
A Systemwide Approach to Managing the Risks of Continuous Manufacturing
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A Systemwide Approach to Managing the Risks of Continuous Manufacturing

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.

Agile, Data-Driven Life Cycle Management for Continuous Manufacturing
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Agile, Data-Driven Life Cycle Management for Continuous Manufacturing

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...

USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics
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USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics

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.

A Proposal for a Comprehensive Quality Overall Summary
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A Proposal for a Comprehensive Quality Overall Summary

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.
CMC Requirements for New Drug Registration in Latin America
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CMC Requirements for New Drug Registration in Latin America

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...

Addressing the shortage of skilled workers
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Addressing the shortage of skilled workers

The success of the biopharmaceutical industry and the expansion of manufacturing facilities, of both existing companies and newcomers, has put a strain on the number of temporary and permanent skilled workers needed to fill many positions in the Triangle.

Sustainability Definitions for the Pharmaceutical Industry
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Sustainability Definitions for the Pharmaceutical Industry

While financial investment in novel therapies provides patients with new treatment options and improved quality of care, the pharmaceutical industry also recognizes its responsibility to transition toward more sustainable development, manufacturing, and stewardship of medicines throughout their life cycle.

A New Regulatory Approach to Drive Sustainable Medicines
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A New Regulatory Approach to Drive Sustainable Medicines

To enable changes across the pharmaceutical industry, sustainability should be included alongside quality, efficacy, and safety when assessing medicines. This article reviews two case studies that cover sustainable pack types and extension of shelf life. With the drive to manage unmet medical need through acceleration of drug development programs, postapproval sustainability variations will...

Challenges for Net Zero Carbon Pharmaceutical Manufacturing
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Challenges for Net Zero Carbon Pharmaceutical Manufacturing

The scientific community accepts that greenhouse gas (GHG) emissions cause global warming and climate change.1

  • 1Intergovernmental Panel on Climate Change (IPCC). “Sixth Assessment Report: Climate Change 2021: The Physical Science Basis.” Finalized 9 August 2021.
Environmental Sustainability in Biopharmaceutical Facility Design
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Environmental Sustainability in Biopharmaceutical Facility Design

Many emerging tools and technologies support the environmental sustainability of the pharmaceutical industry. In facility design, solutions are derived through science-based analyses of environmental impacts from the materials, processes, services, and architecture. From greener energy sources to a reduction in the type and amount of emissions, we are seeing improvement in this sector’s...

Sustainability: Corporate Ambition, Governance, & Accelerated Delivery
Features
Sustainability: Corporate Ambition, Governance, & Accelerated Delivery

The imperative for global action to tackle climate change is clear and the pharmaceutical industry has a key role to play. Governments have entered into international commitments to reduce climate impact (carbon emissions) and protect nature (water, land, air, and biodiversity) with policy frameworks established to facilitate and drive progress against agreed targets.1

  • 1United...
Case Study: Meeting Manufacturing Needs with a Net Zero Energy Facility
Features
Case Study: Meeting Manufacturing Needs with a Net Zero Energy Facility

The expected FDA approval for a Treprostinil dry powder inhaler revealed a need for the manufacturer to expand its warehousing and logistics capabilities to support its growing operations. The company’s senior leadership wanted to ensure this expansion came with as minimal an impact on the environment as possible, so a key priority was to provide a net zero energy facility. With a vision for...

The Road to Explainable AI in GXP-Regulated Areas
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The Road to Explainable AI in GXP-Regulated Areas

Recent advances in artificial intelligence (AI) have led to its widespread industrial adoption, with machine learning (ML) algorithms demonstrating advances in performance in a wide range of tasks. However, this comes with an ever-increasing complexity of the algorithms used, rendering such systems more difficult to explain.1

  • 1Samek, W., and K. R. Müller. “Towards Explainable...

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Proper Cleanroom Wiping Techniques
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Proper Cleanroom Wiping Techniques

In cleanrooms and other critical environments, it’s important to understand the role that proper wiping technique plays in reliable and consistent contamination control. When cleaning contamination you cannot see, technique is a sure way to know you’ve covered the surface area in question.

The Next Generation of Pat Tools To Measure the Advance of the Sublimation Front in a Freeze-Drying Process
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The Next Generation of Pat Tools To Measure the Advance of the Sublimation Front in a Freeze-Drying Process

Industrial freeze-drying processes increasingly demand the use of wireless, battery-free, and accurate temperature sensors which allow a deeper understanding of the lyophilization process and monitor in real-time product behaviour. The new Sublime sensors aim to respond to this growing need with their wireless power transmission and communication, and multi-point measuring system consisting of...

Pharmaceutical Industry Trends
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Pharmaceutical Industry Trends

Much like a chain is only as strong as its weakest link, a pharmaceutical cleanroom is only as sterile as its most unhygienic element. Even the smallest microorganism can spoil or degrade entire batches of pharmaceuticals and hygiene-sensitive products. That’s why it is essential that all equipment, tools, and personnel in a cleanroom are—in fact—clean.

Engineering of a Pharmaceutical Project
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Engineering of a Pharmaceutical Project

This article explores the complexity of pharmaceutical engineering and offers a concise overview of crucial engineering practices essential for successful project design and execution. This piece offers a succinct overview of how these engineering principles intersect with the qualification process, a vital step in securing regulatory approval. We focus on the vital role that engineering plays...

EU MDR: What’s New and What's Challenging?
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EU MDR: What’s New and What's Challenging?

The European Union's Medical Device Regulation (EU MDR), which came into effect in May 2021, has not only brought about significant changes to safety requirements but has also presented the medical device industry with a host of new challenges. Register to download this whitepaper to…

  • Understand the new safety requirements of the EU MDR and how they impact...
Paving the Road to Allogeneic Car-T Therapy Manufacturing
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Paving the Road to Allogeneic CAR-T Therapy Manufacturing

The demand for cell and ex-vivo gene therapies is steadily increasing, given the impressive efficacy of autologous chimeric antigen receptor T-cell (CAR-T) therapies against hematological malignancies. In recent years, the reality of curative treatment and commercial approval of several autologous CAR-T products triggered developers to plan for increased capacity and treating larger patient...

Latest Articles

Annex 1 in Force! Join the First Discussion after the 25 August Effective Date
iSpeak Blog
Annex 1 in Force! Join the First Discussion after the 25 August Effective Date

PIC/s Annex 1, and the WHO Annex 2 for the manufacturing of sterile products took effect on 25 August 2023, and the time to attend the 2023 ISPE Pharma 4.0™ and Annex 1 Conference couldn’t be better. The Equipment Innovation and Annex 1 Implementation Track Co-leads Richard Denk and Matthew Gorton and the Emerging Leader Co-lead Pol Bonet invite you to join them for this exciting event in...

Regulatory, Compliance and Quality Challenges, Learnings, and Future Opportunities
iSpeak Blog
Regulatory, Compliance and Quality Challenges, Learnings, and Future Opportunities

The pharmaceutical industry is constantly evolving, placing a significant emphasis on emerging technologies that facilitate quicker access of medications for patients globally. This unceasing drive for innovation and improvement has led the industry to embrace cutting-edge technologies like data analytics, machine learning, and artificial intelligence. These technologies are not just trends;...

ISPE GAMP SIG MES Planning to Move the Industry Forward
iSpeak Blog
ISPE GAMP SIG MES Planning to Move the Industry Forward

With a recent increase in interest and participation, the ISPE GAMP® Special Interest Group (SIG) focusing on Manufacturing Execution Systems (MES) has mapped out an ambitious number of subject areas to use as the basis for future publications, presentations, and best practice guidance documents. With the co-leadership of Christian Wöelbeling, Executive Industry Advisor at Körber Pharma...

Member Spotlight: Danielle Gabrish
iSpeak Blog
Member Spotlight: Danielle Gabrish

Danielle Gabrish is the Director of Clinical Biologics at AstraZeneca and the Chair of the ISPE Women in Pharma® group for ISPE’s Chesapeake Bay Chapter. She’s also a mom, mentor, and advocate for women and Emerging Leaders.

Advanced Therapy and Advanced Manufacturing for Unmet Medical Needs
iSpeak Blog
Advanced Therapy and Advanced Manufacturing for Unmet Medical Needs

Addressing the unmet healthcare & medical needs is among the top priorities for global governments and organisations, including the pharmaceutical industry. We are facing unprecedented challenges due to the change with medical knowledge doubling every 72 days1

  • 1Peter Densen, “Challenges and Opportunities Facing Medical Education,” Transactions of the American Clinical and...
The Conference provided a forum for experts in the Chinese biomedical and pharmaceutical engineering field.
iSpeak Blog
Revolutionizing Biopharma Engineering: Key Takeaways from the 2023 Global Biopharma Engineering Forum and Ispe China Conference

Shanghai ISPE Pharmaceutical Information Company (SPIC) held the 2023 Global Biopharma Engineering Forum and ISPE China Conference in Hangzhou, China on 26-27, May 2023. Mr. Ping Zhang, Chairman of SPIC and the ISPE China Committee, introduced ISPE and provided an in-depth analysis of the prospects of domestic and foreign bio-pharmaceutical enterprises. The in-depth discussions from this...

Cloud-Based Pharma
iSpeak Blog
Implementing Cloud-Based Pharmaceutical Plant Management Software: Data Security Considerations

Cloud-based systems for plant process management (PPM)1

  • 1Important to Note: In the context of industrial processes and manufacturing, plant process management (PPM) refers to the systematic planning, implementation, and control of processes to ensure efficiency, quality, and productivity in a production environment. This involves optimizing workflows, resource allocation, and...
ISPE Briefs: ISPE Initiatives Provide Guidance on Medicines Supply
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ISPE Briefs: ISPE Initiatives Provide Guidance on Medicines Supply

ISPE task teams created reports and a model to examine the challenges surrounding drug shortages, emergency preparedness, and the supply chain of active pharmaceutical ingredients (APIs). This article outlines ISPE task teams created reports and a model to examine the challenges surrounding drug shortages, emergency preparedness, and the supply chain of active pharmaceutical ingredients...

Emerging Leaders Editorial: Zen-Zen Yen
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Emerging Leaders Editorial: Career Development Powered by AI

The healthcare field is being transformed by artificial intelligence (AI) in remarkable ways, providing never-before-seen chances to enhance the well-being of patients. And the use of AI is transforming the job market and bringing numerous benefits to both employees and employers.

Establishing Data Governance within the Digital Validation Sector
iSpeak Blog
Establishing Data Governance within the Digital Validation Sector

Data Governance is currently utilized in many areas of business and government including finance, banking, telecommunications, and by the agencies regulating these industries. In pharmaceuticals, digital validation is still at a relatively early stage of the digital transformation journey where data governance is currently managed in silos of data (Industry 3.0) and the industry has of yet to...

Continuous Manufacturing of Small Molecule Drug Substances
Online Exclusives
Continuous Manufacturing of Small Molecule Drug Substances

The adoption of continuous manufacturing (CM) in the pharmaceutical industry is increasing because of the advantages and opportunities it offers, including the ability to handle hazardous reactions, a higher degree of process integration, and improved sustainability. This article discusses the considerations and approaches adopted by Pfizer, Eli Lilly, GSK, and Amgen in designing and...

Member Spotlight: Tracy Jamerson
iSpeak Blog
Member Spotlight: Tracy Jamerson

Tracy Jamerson is the Chapter Manager for the ISPE Midwest Chapter. She brings 10+ years of experience to the pharmaceutical industry, currently working as the Office Coordinator at Compli, - a wholly-owned subsidiary of George Butler Associates. Compli is part of the Life Sciences Division. GBA is multi-disciplinary. In this role, she is responsible for a variety of duties, including Project...

Current Issue

Pharmaceutical Engineering

September / October 2023

Risk Management for Avoidance of Drug Shortages Cover: Shortages of essential medicines around the world have been an ongoing concern for patients, caregivers, and regulators and have been exacerbated by the COVID-19 pandemic. Many regulators have instituted requirements for reporting potential or actual drug shortages. To further minimize drug shortages, regulators in the United States and France...