Featured Articles

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....
Features
The Pharma 4.0™ Special Interest Group is focusing on key technologies that will modernize pharmaceutical manufacturing and facilitate digital transformation. These technologies include digital twins, augmented reality, artificial intelligence, big data and analytics, mobiles, cloud, advanced...
Features
To facilitate the assessment and mitigation of compliance risks associated with a third-party service organization, its services, and the systems used to provide the services, this article proposes adopting an approach from the financial sector that, with a little modification, could be used to...
Features
To meet the EU serialization deadline on 9 February 2019, pharmaceutical companies and their contractors have had to reorganize their manufacturing lines and logistics to ensure compliance with the EU’s Falsified Medicines Directive (FMD) of 2011 and the EU Commission Delegated Regulation 2016/161...
Features
Continuous manufacturing (CM) is an advancement in pharmaceutical manufacturing technology that provides high assurance of product quality as well as enough flexibility and agility in production to respond to market demands. The decision to invest in CM can be challenging for a company given the...
Features
The 2018 ISPE Biopharmaceutical Manufacturing Conference on 10–12 December in Huntington Beach, California, provided information about future-oriented developments in the burgeoning area of biopharmaceutical manufacturing—and also shared insights into the achievements that are already underway....
Features
This article examines patient preferences in one facet of clinical research: the experience related to the use of investigational medicinal products (IMPs). As patients have become more involved and informed in their healthcare choices, the “voice of the patient” has been increasingly incorporated...
Features
It is the duty of the government to improve access to safe, effective, and quality medicines for its constituents. Various approaches are taken by different countries to achieve this; for the Philippines, the approach is through the active promotion of...

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Latest Articles

iSpeak Blog
The 2020 ISPE Aseptic Conference starts in one week! Here's all the info you need to make the most of your experience. Conference Essentials Conference AgendaTravel Information Registration and Information Hours Sunday, 1 March | 1300–1700 Monday, 2...
iSpeak Blog
If you work in the parenteral manufacturing space, it’s a foregone conclusion that you can pinpoint the emotion and anxiety that comes from receiving word that the FDA has arrived at your facility for an inspection. If Billy Joel were to pen the lyrics...
iSpeak Blog
The theme of “Proactive Career Design” for the Women in Pharma® (WIP) Breakfast Session at the 2020 ISPE Facilities of the Future conference on 31 January in San Francisco was a fitting one: design and implementation apply equally well to careers as to...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from January 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
“I’ve never received such useful advice about my career before. I came to the event last year but I still learned so many new ideas and tips this year,” says Megha Shah, a Chemical Engineering Student from UMass Amherst. Megha was one of the many...
iSpeak Blog
Deborah A. Geyman Deborah Geyman became interested in pharma while still in high school; today, after working in the industry for three decades, she is...
iSpeak Blog
I have been going to the ISPE Aseptic Conference since 2008 and the overwhelming response is that this is the best technical conference that ISPE hosts. The amount of learning, networking, and understanding that you can get at this conference is...
iSpeak Blog
“The grass is not always greener.” Have you ever been told that before? When I went to my long time mentor 13 years ago to let her know that I was resigning from our company those were the words she spoke to me. I took her words to heart, but still felt...
iSpeak Blog
Aseptic filling of parenterals is one the most challenging tasks within pharmaceutical manufacturing. There is a wide range of topics that fall under this umbrella, from more engineer-driven topics like filling accuracy and machine performance to key...
iSpeak Blog
The 2020 ISPE Facilities of the Future Conference Thursday! Here's all the info you need to make the most of your experience. Conference Essentials Conference AgendaTravel Information Registration and Information Hours Thursday, 30 January 2020 |...
iSpeak Blog
One of the most popular travel destinations for famous movie sites and excellent culinary options, San Francisco will host the 2020 ISPE Facilities of the Future conference. During your free time at this year’s conference, explore creative pieces of...
InTouch
A new ISPE Special Interest Group (SIG) has been formed under GAMP® to address the increasing use of cloud services. A conversation with Michael Osburn, Head of Quality at Cornerstone OnDemand, and Judy Samardelis, IT Quality Director at Thermo Fisher...
Insights
On 26–27 October 2019, the first Global Student & Young Professional Hackathon was held at the 2019 ISPE Annual Meeting & Expo. Thirty-six ISPE Young Professional and Student members came from around the world to participate in the two-day event that demonstrated innovative thinking, collaboration,...
iSpeak Blog
Each year many people start off with how they are going to be better than the year before and write down unrealistic goals about their professional and personal time next the 365 days. Our team at Women in Pharma® has sat down and put together a...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from December 2019. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last...
Insights
As I sit at my computer to write my first column as ISPE International Board Chair, my thoughts are centered on how I can personally help drive our unifying vision, “Connecting Pharmaceutical Knowledge,” and how we as members of ISPE have an outstanding opportunity in the year ahead to provide...
Insights
The pharmaceutical industry is ever-changing, as we saw demonstrated during the 2019 ISPE Annual Meeting & Expo, and at other ISPE conferences around the world. In fact, change is accelerating—and to support the trends and developments in the industry, ISPE has developed a new three-year Strategic...
InTouch
Since its inception at the ISPE 2016 Annual Meeting & Expo, Women in Pharma® (WIP) has been rapidly growing. In the US and Europe, the society has held numerous Women in Pharma® events at local Affiliates, Chapters, and Annual Meetings & Expos, and it is now establishing a presence in Asia. On 27...
Technical
The Advanced Digital Design of Pharmaceutical Therapeutics (ADDoPT) project“ADDoPT—Advanced Digital Design Transforming Pharmaceutical Development and Manufacture.” Accessed 1 September 2019. https://www.addopt.org is a recently completed UK-based design manufacture and supply chain research...
Technical
According to US Pharmacopeia (USP) Chapter <790>, “all parenteral products should be essentially free from any visible particles.”United States Pharmacopeia. USP Chapter <790>: Visible Particulates in Injections. This is the first and foremost requirement stated in all pharmacopeia for...
InTouch
ISPE’s online site for Pharmaceutical Engineering was launched a little over one year ago, in November 2018. Here are some statistics about the site’s success during its first year.
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup are the top 10 blog posts from iSpeak in 2019. Gain key insights on FDA process validation guidelines, Pharma 4.0 developments, and more on what the pharmaceutical industry has explored and accomplished...

Current Issue

January / February 2020

Introducing Industry Leaders: Pharmaceutical Engineering® is launching a new series of profiles of industry leaders. This ongoing series will look at the lives and careers of individuals who are changing the face of the pharmaceutical industry. An Advocate for Quality: Ranjana B. Pathak Ranjana Pathak has spent nearly 40 years in the pharmaceutical industry. Currently the President and Global Head...