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Features
This second of a two-part series explores digital transformation and digitalization in the biopharmaceutical industry with information about how data science enables digitalization along the product life cycle. (Part 1 was published in the March-April 2021 issue of Pharmaceutical...
Features
Cloud computing can be described as networked access and utilization of configurable computing resources such as data and information storage, processing capabilities, applications, and other services on computerized systems provided and/or maintained by a remote organization. As life sciences...
Features
In 2021, the ISPE GAMP® Community of Practice (CoP) is celebrating 30 years of promoting industry good practice for computerized systems and encouraging technical innovation and progress, while protecting patient safety, product quality, and data integrity.
Features
Real-world evidence (RWE) is clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD) relating to patient health status and the healthcare delivery.US Food and Drug Administration. “Use of Real-World Evidence to...
Features
The fourth Industrial Revolution (also known as Industry 4.0) is the era of smart machines, storage systems, and production plants that can autonomously exchange information, trigger actions, and control operations free of any human intervention. To ensure future success in the delivery of...
Features
Digital transformation and digitalization are on the agenda for all organizations in the biopharmaceutical industry. But what are the main enablers of intelligent manufacturing? We hypothesize that data science–derived manufacturing process and product understanding is the main driver of...
Features
During the ISPE Pharma 4.0™ Virtual Conference, the Management Communication working group of the ISPE Pharma 4.0™ Special Interest Group (SIG) held a workshop to support ISPE members in pitching, shaping, and presenting a Pharma 4.0™ project/program to company management.
Features
Across every industry today, digitalization is driving the use and value of data to disrupt traditional business models and ways of working. In pharmaceuticals, the promises of Industry 4.0 are expected, and needed, to finally modernize the legacy approaches that have evolved since the 1970s....
InTouch
The ISPE Aseptic Conference will celebrate its 30th year with the virtual conference on 15–17 March. The conference has been setting the pace for the evolution of sterile manufacturing processes and technologies in the pharmaceutical industry. This year’s virtual conference platform is providing a...
Features
A fundamental GMP requirement is that processes, systems, and methods used to produce medicines and treatments are validated, meaning their fitness for a purpose is demonstrated. If Industry 4.0 is to succeed in the pharma space as Pharma 4.0™, we need new paradigms for validation across the value...
Features
Through this difficult time of the COVID-19 pandemic, ISPE has remained active. At the 2020 ISPE Pharma 4.0™ Virtual Conference, 17–18 November, 174 attendees gathered online to discuss and learn about the progress of the pharma-specific industry 4.0 approach, Pharma 4.0™ (now a registered...
Features
ISPE has announced the launch of its Advancing Pharmaceutical Quality (APQ) Program with the publication of the ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System, a guide dedicated to the topic of CAPA. This article describes how the APQ Program has been built and summarizes the...
Features
This article describes the Pharmaceutical Equipment Exposure Measurement Database (PEEM-DB), which was launched in July 2019 by the ISPE Japan Affiliate for its members. PEEM-DB is offered as a tool for rationally advancing optimal containment equipment settings by collecting exposure measurement...
Features
Personnel management is the most challenging variable in maintaining current Good Manufacturing Practice (cGMP) across the life cycle of drug manufacture, safety, and supply. A standard operating procedure (SOP) outlines agreed-upon instructions for personnel training and instructions for...
Features
Drug developers know that the odds of anyone compound demonstrating safety and efficacy for a disease and its affected populations are low. How can drug developers improve these odds and increase the efficiency and effectiveness of drug development? One useful tool is model-informed drug...
Technical
Recently, recalls of angiotensin receptor antagonists, particularly valsartan, and warning alerts about N-nitrosodimethylamine (NDMA) impurities in drug substances such as ranitidine and metformin have demonstrated the urgent need for manufacturers and regulators to control impurities throughout...
Technical
Online water bioburden analyzers (OWBAs) are analytical instruments providing real-time or near real-time measurement of bioburden in purified water systems.Cundell, A., O. Gordon, N. Haycocks, et al. “Novel Concept for Online Water Bioburden Analysis: Key Considerations, Applications, and Business...
Technical
The process life-cycle model, as discussed in the US FDA guidance on process validation, is a significant change in how we view validation.US Food and Drug Administration. “Guidance for Industry. Process Validation: General Principles and Practices.” January 2011....
Features
Joydeep Ganguly, who is currently Senior Vice President, Corporate Operations, at Gilead Sciences, Inc., places a premium on working for a mission-oriented company. “If you choose the right company with the right ethos and a deep, tangible commitment to the patients, the mission is not just...
Features
Pharmaceutical companies rely on automated vision inspection (AVI) systems to help ensure product safety. Although these systems overcome challenges associated with manual inspection, they can be hindered by limitations in their programming—if the system is programmed to consider every variation in...
Features
As biopharmaceuticals have become a major part of the pharmaceutical industry, we have witnessed significant transformations in product development, strategy, technology, and operations. This ongoing transformational process was the main theme of the fourth annual ISPE Europe Biotechnology...
Features
Oligonucleotides are a relatively new class of drugs, composed of natural and synthetic nucleotides, which primarily include small interfering RNA (siRNA), micro RNA (miRNA), and antisense oligonucleotide (ASO). These molecules achieve therapeutic effects through RNA interference, degradation, or...
Features
In many critical ways, the design of facilities for multiple cell therapy processes is unlike the design of conventional pharmaceutical facilities. This article surveys several of the key issues to consider when designing facilities capable of manufacturing multiple cell therapies, including...

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iSpeak Blog
Early in March 2020, many around the world viewed the sight of collapsing intensive care units in Northern Italy, overwhelmed by COVID19, with great anxiety and we wondered how we might address the inevitable arrival of the virus at our doorsteps. This concern led to a home-grown initiative in...
iSpeak Blog
ISPE is pleased to announce that its Drug Shortages Initiative Task Team is launching a new phase of work to focus on business continuity planning for the prevention of drug shortages. We invite your company to participate. The first activity is a benchmarking study that will launch in May 2021 and...
iSpeak Blog
You are an active and engaged ISPE Member! You sit on the ISPE Board of Directors, the ISPE Foundation Board, and the Steering Committee of Women in Pharma®.  Can you share some of your experiences with ISPE and some of the many successes you have accomplished?
Technical
One of the goals of the cleaning validation design phase is to define critical process parameters (inputs) and acceptance criteria (outputs) of the cleaning process. This article explores the selection of a master soil as part of the cleaning validation design phase for automated parts washers. The...
Technical
What if the reliability of a system could be improved by accessing the standard data provided with modern process instrumentation? These data, accessed from existing instrumentation, can be used to analyze the fitness of processes, equipment, and instruments; better understand processes; support...
InTouch
ISPE Emerging Leaders (ELs) held the first fully virtual International Hackathon in February. Fifty-one participants from over 22 countries encountered real-life challenges with working remotely and across time zones. Innovation was key to generating solutions to the problem statement provided by...
Insights
2020 was a year for finding new ways of working for the entire ISPE Emerging Leaders (EL) community. In February, Emerging Leaders stepped up the challenge by holding the first fully virtual International Hackathon. With over 22 countries represented, the Hackathon required the participants to...
Insights
This year’s Women in Pharma® (WIP) theme of “Fueling the Fire” harnesses the energy and passion that drive women to achieve career advancement, personal growth, and satisfaction. The 3 March webinar focused on the Diversity & Inclusion theme, where we discussed what we as leaders can do to drive...
Insights
I used to think “home detention” was no punishment at all, but this last year has dramatically changed my thinking. Despite working from home for over a year, my house is a wreck! Like many of you, I feel busier than ever, despite not traveling and not driving to and from work. Disruption used to...
iSpeak Blog
Prathiba Sampath, PMPFor me, both personally and professionally, 2020 started off as an incredible year. My husband and I were expecting the arrival of our first child in April. At work, I was being entrusted with increasing responsibilities and being groomed for a promotion, while having an...
iSpeak Blog
The UK Entered a New Relationship with the European Union on 1 Jan 2021 The United Kingdom (UK) (England, Northern Ireland, Scotland and Whales) is no longer part of the European Union (EU) Customs Union. Simply put, it means movement of goods between the UK and the EU are now to be an import and...
Online Exclusives
Robotic process automation (RPA) software automatically handles manual, repetitive, time-consuming, and highly structured tasks such as data entry and back-office functions. Certain processes specific to the pharmaceutical industry represent strong candidates for RPA implementation, with...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from March 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
iSpeak Blog
You have been an ISPE Member for 30 years! During that time, you have done so much for the Society (thank you!). Currently, you are the Co-Chair of ISPE Women in Pharma® and serve as a Board Member for the ISPE International Board of Directors and the ISPE Foundation Board. You have also worked...
iSpeak Blog
As the third (already!) month of 2021 is rapidly coming to its close, it is time for a recap and a look ahead. In the spirit of March being Women’s History Month, we’re taking this opportunity to focus on the women in our organization. Here’s a reflection on and celebration of some exciting past...
Online Exclusives
Industry 4.0 is the recent movement toward intelligent automation technology. In this new era, the integration of modern manufacturing skills and novel information technologies plays an important role on economic competitiveness.Zawadzki, P., and K. Żywicki. “Smart Product Design and Production...
iSpeak Blog
While I consider myself a long-time entrepreneur, the journey to begin my own consulting business started in Seattle over dinner with two colleagues. We were talking about what we want to do in our individual lives and sharing ideas about what those lives might look like. We discussed how our...
iSpeak Blog
The past, present, and future were featured in the Opening Plenary Session at the 2021 ISPE Aseptic Conference. A record number of attendees at the virtual conference hear remembrances of the 30 years of the conference, as well as a look at the present and evolving future of risk reduction,...
iSpeak Blog
What Does Contract Manufacturing Look Like In Pharma? Many factory productions can be outsourced to contract manufacturers (CMs) in order for businesses to continue providing quality products to their customers in a cost-effective way, and so they can focus on other aspects of their business,...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from February 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

Current Issue

May / June 2021

IT Services: Applying Good IT Practice and Automation Cover: This article focuses on pragmatic quality- and risk-based approaches to IT infrastructure. It covers recommendations made by a US FDA/industry team linked to the US FDA Center for Devices and Radiological Health (CDRH) Case for Quality initiative—which is promoting a risk-based, product quality, and patient-centric approach to...