Machine Learning Risk and Control Framework
Machine Learning Risk and Control Framework
Features
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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 are met within the life sciences industry. By leveraging specialized frameworks and methods, we compiled a holistic framework to dynamically identify, assess, and mitigate risks when AI and ML features are in use.

Featured Articles

Quality Considerations in Disaster Recovery: A Case Study
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Quality Considerations in Disaster Recovery: A Case Study

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,...

The Use of Infrastructure as Code in Regulated Companies
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The Use of Infrastructure as Code in Regulated Companies

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...

Leveraging GAMP® 5 Second Edition for Medical Devices
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Leveraging GAMP® 5 Second Edition for Medical Devices

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...

Cold Systems as a Solution to Decarbonize Water Purification
Technical
Cold Systems as a Solution to Decarbonize Water Purification

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...

Calibration Performance Improvement Case Study
Technical
Calibration Performance Improvement Case Study

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...

Figure 1: Experts were asked “Do you see any of the following as a weak point in successful cell therapy manufacturing.”
Technical
Using Industry Survey Data to Shape Cell Therapy Facility Design

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...

CoP Leader Profile: Charlie Wakeham
InTouch
CoP Leader Profile: Charlie Wakeham

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...

CoP Leader Profile: Lorrie Vuolo-Schuessler
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CoP Leader Profile: Lorrie Vuolo-Schuessler

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...

Delivering Curative Therapies: Autologous vs. Allogeneic Supply Chains
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Delivering Curative Therapies: Autologous vs. Allogeneic Supply Chains

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.

Optimizing Cost of Goods for Cell Therapy Manufacturing
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Optimizing Cost of Goods for Cell Therapy Manufacturing

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.

Live Biotherapeutic Products: Moving the Microbiome to the Patient
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Live Biotherapeutic Products: Moving the Microbiome to the Patient

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...

Comparability Considerations for Cellular & Gene Therapy Products
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Comparability Considerations for Cellular & Gene Therapy Products

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.

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.

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...

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Latest Articles

scientist-analyzing-liquid-using-protective-equipment-indoors-Image by vecstock on Freepik
iSpeak Blog
Empowering the Aseptic Workforce: Training and Continuous Learning as an Enabler for Success

In the pharmaceutical industry, which is highly regulated, aseptic processing is a critical component that ensures the sterility of products. Regulators have a set of comprehensive requirements that minimize the risk of contamination. Regulators set the requirements; however, the industry has an obligation to the patients who rely on and expect a drug that is safe and free of contamination....

Manufacturing Execution Systems (MES): Beyond ROI, a New Look at Business Payback
iSpeak Blog
Manufacturing Execution Systems (MES): Beyond ROI, a New Look at Business Payback

Like any investment in digital manufacturing systems, demonstrating business payback before and after investment is critical to getting MES projects approved and verifying profitability after investment. Whether it is introducing MES, expanding it to additional sites, switching software, upgrading existing software, or developing electronic production records (EPR) for new drug products,...

Unveiling the Green Prescription: Navigating Sustainability in the Pharmaceutical Industry
iSpeak Blog
Unveiling the Green Prescription: Navigating Sustainability in the Pharmaceutical Industry

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...

20 Important Quotes That Will Change Your Company Culture: Part Two- ISPE’s Women in Pharma© Leaders Focus on Leadership Agility and Inclusivity at the 2023 ISPE Pharma 4.0 and Annex 1 Conference
iSpeak Blog
20 Important Quotes That Will Change Your Company Culture: Part Two - ISPE’s Women in Pharma Leaders Focus on Leadership Agility and Inclusivity at the 2023 ISPE Pharma 4.0 and Annex 1 Conference

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.

Peer Companies Share Knowledge on Predictive Maintenance & KPIs in Recent Asset Management Benchmarking Session
iSpeak Blog
Peer Companies Share Knowledge on Predictive Maintenance & KPIs in Recent Asset Management Benchmarking Session

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...

ISPE Hosts a Fireside Chat with FDA Commissioner
InTouch
ISPE Hosts a Fireside Chat with FDA Commissioner

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,...

Beyond the Podium
iSpeak Blog
Beyond the Podium: Insights from Two #ISPEFoF 2024 Keynote Speakers

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....

Golf Tournament Supports ISPE Foundation
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Golf Tournament Supports ISPE Foundation

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.

ISPE Briefs: New Good Practice Guide Covers Pharmaceutical Gas Systems
InTouch
ISPE Briefs: New Good Practice Guide Covers Pharmaceutical Gas Systems

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...

2023 Committee of the Year - Advancing Pharmaceutical Quality
iSpeak Blog
A Committee Built Upon Excellence

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.

Advancements in Cell and Gene Therapy Manufacturing
iSpeak Blog
Advancements in Cell and Gene Therapy Manufacturing

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...

dna-Image by kjpargeter-on Freepik
iSpeak Blog
ATMP Cleanroom Facilities: A Roadmap for Success

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.

Preparing our Teams for the Facilities of the Future
iSpeak Blog
Preparing our Teams for the Facilities of the Future

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...

New Trends: Green Engineering, Sustainability through a Proper Design
Sponsored Content
New Trends: Green Engineering, Sustainability through a Proper Design

In today’s situation, sustainability is a more critical concept in engineering projects. Sustainability is related to the ability to meet the needs of the present without compromising the ability of future generations to meet their own needs. In other words, sustainability is about ensuring that we leave the world in a better condition than we found it.

In the design stage, where...

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Sponsored Content
Improving Production Process with Simulation

As we strive towards an efficient and robust production process, questions regarding achievable production capacity, utilization of equipment, and possible optimization arise. These questions can be answered by taking a holistic approach towards the entire production process. The creation of batch plans, the identification of bottlenecks, as well as the analysis of media consumption and...

Current Issue

Pharmaceutical Engineering

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...