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Pam Cheng is Executive Vice President, Global Operations & Information Technology, at AstraZeneca, a United Kingdom–headquartered pharmaceutical company with more than 60,000 employees. In this role, she combines her expertise as an engineer with business savvy and seeks opportunities to lead her...
Features
As the old saying goes, “Time is money.” In today’s industrialized world, this adage is profoundly true. Manufacturers can no longer afford to overlook operational excellence. A new production philosophy called “Lean manufacturing” has been developed to save as much time as possible during...
Features
At the 2019 ISPE Global Pharmaceutical Regulatory Summit, regulators updated attendees on approaches to industry innovations and the ongoing work on harmonization and reliance around the world.
Features
Virtually every ISPE member has at least one story to tell about how health authority inspections or the review and approval of regulatory applications have affected their efforts to supply critically needed medications to patients globally. Although these stories may emphasize the considerable...
Features
Annex 2 is the Good Manufacturing Practices (GMP) document by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) addressing manufacture of biological medicinal substances and products for human use. This article shares information about Annex 2 and ISPE’s submitted comments to the draft...
Features
This article introduces the concept of robotic process automation (RPA) and discusses how the technology may be used within a GAMP® framework to support both non-GxP and GxP processes.
Features
The article appraises the real-world experiences of two pharmaceutical companies approaching the rollout of energy- and water-reduction programs to selected facilities around the world. It is the result of more than two years of collaboration between the company corporate teams, individual site...
Features
Sustainability is a key principle for pharmaceutical companies in 2020. However, translating corporate goals into meaningful improvements can be a challenge, particularly when competing factors such as complex technical requirements or ambitious project schedules are involved.
Features
Medical treatments and pharmaceuticals are indispensable in improving quality of life. In recent years, however, pharmaceutical compounds have become a significant group of environmental pollutants, shown to pose risks to human health and have adverse environmental effects.
Features
Ranjana B. Pathak, BSc (Hons), MBA, DHA, has spent nearly 40 years in the pharmaceutical industry. Currently the President and Global Head of Quality, Medical Affairs, and Pharmacovigilance at Cipla Ltd. in Mumbai, India, Pathak’s long tenure has afforded her an informed perspective on the past,...
Features
Every important cause needs its champion. Champions have a vision of how things should be, and a passion to reach their goals. They are committed and determined to achieve positive results, are willing to do the heavy lifting, and will take consistent and massive action until results are achieved.
Features
Since the early 1990s, when the “upstart” biotech industry realized that its future success would be heavily influenced by the ability to manufacture multiple products within the same facility,Hill, D., and M. Beatrice. “Biotechnology Facility Requirements, Part 1, Facility and Systems Design.”...
Features
Applying emerging technologies can lead to more robust and flexible manufacturing processes that in turn can help the pharmaceutical industry respond to drug shortages, reduce interruptions in production and delivery of medicines, ensure consistent clinical performance of products, and achieve...
Features
As the pharmaceutical industry balances demands for small-batch and blockbuster products and encounters new regulations, there is a need for efficient and safe production technologies that can meet stringent quality and safety requirements for the aseptic filling of drugs. Looking forward,...
Features
Article of the Year 2018 Winner: The winner of the 2018 Roger F. Sherwood Article of the Year award is “Continuous Manufacturing in Biotech Processes: Challenges for Implementation” by Robert Dream, PE, CPIP; Christoph Herwig, PhD; and Emilie...
Features
Moving platforms from development to the delivery of more biopharmaceuticals to more patients is reality, not just a concept, for Moderna, Inc. Juan Andres, the company’s Chief Technical Operations and Quality Officer, presented on “mRNA Medicines—Industrializing a New Platform” at the 2019 ISPE...
Features
The US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program promotes a risk-based, product quality–focused, and patient-centric approach to computerized systems. This approach encourages critical thinking based on product and process knowledge and quality risk management...
Features
Presenters and a panel of FDA regulators and industry experts discussed key regulatory and industry issues during the closing plenary of the 2019 ISPE Biopharmaceutical Manufacturing Conference.
Features
Innovation has been and continues to be a driver for the strides being made in biopharma development and manufacturing, noted Eric S. Langer, President and Managing Partner, BioPlan Associates, Inc., who addressed “Innovation in Transformative...
Features
Cell and gene therapies are the latest revolution in medicine manufacturing. Unlike small molecules or traditional biotech products, these therapies introduce cells and genes into a patient to treat the underlying cause of a disease—they are living medicines.
Features
Innovations in production methods and technologies that enable a competitive and sustainable biopharmaceutical product supply were the focus of presentations at the 2019 ISPE Biopharmaceutical Manufacturing Conference in Boston, Massachusetts, 18–20 June. Future directions for the biopharma...
Special Reports
The 2019 ISPE Annual Meeting & Expo will be held 27–30 October in Las Vegas, Nevada. The theme is “Modernize. Globalize. Transform.” Michael L. Rutherford, Program Committee Chair and Board Ambassador for ISPE, and Executive Director for Computer Systems Quality and Data Integrity at Syneos Health,...
Features
On 5 June 2018, a plenary session entitled ”Patient-Centric Specification” (PCS) was held at the 2018 ISPE Quality Manufacturing Conference in Arlington, Virginia. More than 160 professionals from worldwide innovator and generic pharmaceutical companies, academia, and regulatory agencies attended....

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iSpeak Blog
The design, construction, commissioning, qualification, and continued performance of water and steam systems for the pharmaceutical industry present significant challenges. These systems need to meet Good Manufacturing Practice (GMP) regulations...
iSpeak Blog
Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. Technology transfers take the outputs of process or method development activities and transfers the knowledge to a different...
iSpeak Blog
When we first launched the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) in 2017, we benefited from an incredible enthusiasm and engagement from across the ecosystem. At the time, academic institutions were working to...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from April 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last...
iSpeak Blog
Soon we’ll be gathering on a virtual scale with all our biotech colleagues in ISPE. Never daunted by the challenge of the pandemic, ISPE went right to work on this conference once the crisis hit. This is my fifth conference on the planning group, and I...
iSpeak Blog
COVID-19 pandemic has caused unprecedented change and disruption to each of our daily lives. All of us around the world are touched by the current pandemic, whether it be personal hardship or professional life challenges. We have seen our communities and...
iSpeak Blog
You’ve been with ISPE for 18 years and currently serve as Chair of the ISPE France Affiliate. Can you share some of the highlights of your involvement with the Society during your tenure? During this period, I’ve experienced many highlights! Among them,...
Technical
Over the years, the roles and responsibilities of engineering and quality/validation personnel for commissioning and qualification (C&Q) activities have evolved. Now more than ever, commissioning and qualification approaches based on quality risk management (QRM) principles rely heavily on...
Insights
Did you know that Women in Pharma® (WIP) has launched a program to initiate Mentor Circles around the globe? While great strides have been made to support women in the workplace, women are still significantly underrepresented in upper management in the pharmaceutical industry. The ISPE Women in...
Insights
Spring is finally here, signaling a time of new beginnings. Today finds me thinking about International Women’s Day (IWD, observed annually on 8 March), a global day of celebrating the social, economic, cultural, and political achievements of women. This year, International Women’s Day has the...
InTouch
Thank you to our Members for supporting ISPE and our mission to ensure the availability of quality medicines worldwide.
iSpeak Blog
In recent years significant problems with data integrity have been found in the pharmaceutical, biotechnology, and medical device industries worldwide. This ultimately affects patients, as patient safety is intrinsically impacted by the integrity and...
iSpeak Blog
COVID-19 pandemic has caused unprecedented change and disruption to each of our daily lives. All of us around the world are touched by the current pandemic, whether it be personal hardship or professional life challenges. We have seen our communities and...
Insights
Brazil’s regulatory authority is working hard to make the nation a larger player in the global pharmaceutical market, and these efforts appear to be working: the life sciences industry has expanded in recent years, and market projections are positive. These ongoing developments represent...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from March 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last...
iSpeak Blog
The spectrum of gene therapy with some specificity to viral vectors is very broad including both delivery vehicles developed for transient short-term and permanent long-term expression. Moreover, the types of vectors are represented by both RNA and DNA...

Current Issue

May / June 2020

Regulatory Trends: ICH Q12’s Impact on Product Life-Cycle Management Introducing ICH Q12: A Transformational Product Life-Cycle Management Guideline Cover: The ICH Assembly endorsed the Q12 guideline, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management,” in November 2019. This transformational guideline has a wide scope of applicability across pharmaceutical...