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Features

With the Chinese government initiating drug regulatory reform in 2015 and China joining the International Council for Harmonisation (ICH) in 2017, a significant number of measures have been implemented by the government. The aim is to make fundamental changes to China’s drug regulatory administration system so it can facilitate pharmaceutical development and better meet patient needs in the...

Features

Digital display labels (DDLs) offer an alternative solution to eliminate manual relabeling in the clinical supply chain, optimizing label content updates through a simple, system-controlled approach while providing new, uncharted opportunities. With increased efficiency in making regulatory-compliant changes and enhanced flexibility in the clinical supply chain, DDL technology has the...

Technical

The validation of media and buffer mixing is a continuing area of resource constraint in the pharmaceutical industry. These validations require materials, validation associates’ time, and the use of equipment and processing areas. This article proposes a risk-based life cycle for minimizing mixing validation resource inputs, with the objective of optimizing validation efforts through the use...

Technical

Pharmaceutical manufacturing facilities produce a variety of products, including highly potent products that require safety measures to prevent adverse health effects on patients and operators. To ensure safety, these facilities use containment equipment to minimize the risk of contamination. This article presents criteria for selecting containment equipment, considering both...

Technical

Pharmaceutical critical utilities are typically built of 316L stainless steel; nevertheless, surface degradation has been reported due to the occurrence of different phenomena. This article aims to explain how field electrochemical techniques using a portable tool can be an effective method for surface inspection, qualification, and monitoring. The surface finish assessment considered...

Technical

The world is beginning to grasp the huge challenge of achieving net-zero carbon emissions, or carbon neutrality, by 2050. Many countries have committed to achieving this ambitious goal. As a major global industry, the pharmaceutical sector has a significant role to play. For thermal energy–intensive industries, such as pharmaceutical manufacturing, the long-term future options to maintain...

InTouch

The impact people have on others’ lives is not always obvious. For many, the Advil mini pill might not seem like a big deal, but for people who have trouble swallowing pills, like cancer patients, the tiny pill has made a huge difference in their ability to manage pain. It’s projects like that, as well as treatments for bladder cancer and transthyretin amyloidosis, that Tammy Spain is most...

Features

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...

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.

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Latest Articles

iSpeak Blog

It is an exciting time in life sciences. Many companies have focused initial artificial intelligence/machine learning (AI/ML) adoption efforts on developing and implementing ML trained algorithms, which necessitate following a controlled approach such as the GAMP® 5 ML Sub-System methodology shown below. This blog highlights key artifacts and considerations when implementing AI/ML for GxP use...

Technical

As the pharma industry moves to an ambitious Validation 4.0 paradigm, computerized systems play a pivotal role in enabling the rapid transition. Innovation and agility in computerized system validation (CSV) received a strong push in the second half of 2022 with the publication of the FDA draft guidance on “Computer Software Assurance for Production and Quality System Software”

iSpeak Blog

ISPE’s Regulatory Quality Harmonization Committee (RQHC) is structured with four Regional Focus Groups (RFGs): Asia-Pacific, Europe/Middle East/Africa, Latin America, and North America. The RFGs support ISPE in its understanding and response to regulatory issues and concerns for the specific region. The RQHC Asia-Pacific RFG includes pharmaceutical professionals located in or having specific...

iSpeak Blog

Aaron Bober is an active member of ISPE, the ISPE Women in Pharma® Boston Chapter, and the ISPE Women in Pharma International Steering Committee. He is based in the Boston, Massachusetts, area and serves as the Director of Engineering, New England, at IPS. Bober developed the below testimonial, recounting his personal experience and investment in supporting women in the pharmaceutical industry...

iSpeak Blog

With well over a century of history and change, the first International Women's Day was held in March 1911. International Women's Day is a day of collective global activism and celebration that belongs to all those committed to forging women's equality.

InTouch

The new year is here and, with that, another International Women’s Day approaches! This incredibly important global movement, which takes place every 8 March, celebrates women’s achievements, raises awareness about discrimination, and advocates for accelerated equality and gender parity. ISPE’s Women in Pharma® community strives to accomplish all these goals through regional and international...

InTouch

ISPE has more than 21,000 members in more than 120 countries worldwide. As an ISPE member, you have access to this network, which can be exciting and overwhelming at the same time. Connecting at the local level unlocks the unique benefits that your local Affiliate or Chapter holds. Not only is this a career game changer, but it also opens doors of opportunity to experience your ISPE membership...

Insights

Personalized medicine provides a treatment alternative that utilizes patients’ genetic material to produce therapeutics. According to Market Research Future, the US currently accounts for the largest share of the personalized medicine market, and it is expected to reach US $27.5 million by 2030.

iSpeak Blog

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....

iSpeak Blog

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,...

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.

Current Issue

March / April 2024

Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact Cover: The Asia Pacific region (APAC), like any large territory, encompasses a blend of well established and early-stage economies, diverse healthcare systems, and differences in language, culture, politics, and technology adoption. APAC’s size and complexity has created new challenges and opportunities for the pharmaceutical...