Women in Pharma®:Empowering Women as Industry Leaders
Women in Pharma®: Empowering Women as Industry Leaders
Features
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Women in Pharma® is a place where women and men—especially those new to the industry—can access a network of mentors, role models, and educational resources to support their professional success. The widespread global interest and participation in this initiative and its events have shown that women in the pharmaceutical industry are hungry for the connection, mentoring, and education that Women in Pharma offers.

Featured Articles

Figure 4: The ISPE Quality Metrics Initiative/APQ timeline. Key: FDASIA, Food and Drug Safety and Innovation Act; FRN, Federal Register notice.
Features
ISPE’s APQ Program & Guides Advance Pharmaceutical Quality
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...
Figure 1: Examples of graphs generated from PEEM-DB.
Features
A New Pharmaceutical Equipment Exposure Measurement Database
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...
Creating Effective Standard Operating Procedures
Features
Creating Effective Standard Operating Procedures
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...
Model-Informed Drug Development Addresses COVID-19 Challenges
Features
Model-Informed Drug Development Addresses COVID-19 Challenges
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...
Figure 1: Example of fishbone analysis as a tool for risk identification.
Technical
Quality Risk Management to Address Product Impurities
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...
Figure 1: Example of OWBA installation in a WFI system.
Technical
GMP Implementation of Online Water Bioburden Analyzers
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...
Figure 1: Traditional cleaning validation approach emphasizes validating the cleaning process.
Technical
Cleaning Validation Program Maintenance in a Process Life-Cycle Model
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....
Joydeep Ganguly
Features
Industry Leaders: Focused on the Mission
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...
Figure 1: CNN model training process and validation results for a lyophilized vial AVI system.
Features
Vision Inspection Using Machine Learning/Artificial Intelligence
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...
Plenary session at the 2019 ISPE Europe Biotechnology Conference in Brussels in September 2019.
Features
2019 ISPE Europe Biotechnology Conference: Industry Transformations
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...
Current State of Oligonucleotide Therapeutics
Features
Current State of Oligonucleotide Therapeutics
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...
Figure 1: Cell therapy life cycles.
Features
Flexible Facility Design for Multiple Cell Therapy Processes
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...
Figure 1: A global supply scenario with cross-country and cross-cultural interfaces
Features
Operational Risk Management in Global Supply Scenarios
The current regulatory framework in the pharmaceutical industry places pressure on marketing authorization holders (MAHs) to demonstrate quality oversight, and a systematic risk management process is a prerequisite for avoiding compliance and productivity pitfalls. This article focuses on options...
2020 ISPE Annual Meeting & Expo: Driving the Future of Pharma
Special Reports
2020 ISPE Annual Meeting & Expo: Driving the Future of Pharma
The 2020 ISPE Annual Meeting & Expo will be ISPE’s first completely virtual Annual Meeting. As always, there will be great learning and networking opportunities—in fact, the digital format offers greater flexibility for attendees.
Validation of Clinical Trial–Related Systems in Smaller Enterprises
Features
Validation of Clinical Trial–Related Systems in Smaller Enterprises
Existing risk-based approaches to computerized system compliance and validation as outlined in GAMP® 5International Society for Pharmaceutical Engineering. GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems. North Bethesda, MD: International Society for Pharmaceutical...
FOYA Category Winners & Honorable Mentions for 2020
Special Reports
FOYA Category Winners & Honorable Mentions for 2020: Examples of Excellence
Each year, ISPE celebrates innovations and advances in pharmaceutical manufacturing technology with its Facility of the Year Awards (FOYA) program. This year, we added a new category, Social Impact, to recognize companies that developed new standards and practices to prevent drug shortages and...
ISPE France Affiliate: Long-Time Affiliate Continues to Shine
Features
ISPE France Affiliate: Long-Time Affiliate Continues to Shine
The ISPE France Affiliate is fortunate in many ways. The pharmaceutical industry in France is world class, employing close to 100,000 people and generating €55.9 billion in annual revenue.LEEM. “French Pharmaceutical Industry—Key Data 2019.” Accessed 9 July 2020....
Reporting categories for changes in the drug substance (DS) and drug product (DP) process and analytical methods per FDA guidance [
Features
Case Study: Facilitating Efficient Life-Cycle Management via ICH Q12
The latest ICH guideline, ICH Q12,International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised Guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Q12. Final Version.” 20 November 2019....
Achieving Vertical & Horizontal Integration in Pharma 4.0™
Features
Achieving Vertical & Horizontal Integration in Pharma 4.0™
Recent projects on serialization and track and trace help illustrate the concepts of vertical and horizontal integration. With vertical integration, the unique product identification information (serial number, lot, etc.) used by sensors and printers on the packaging lines is made accessible to the...
Regulatory Panel Session: Explores Key Aseptic Topics
Features
Regulatory Panel Session: Explores Key Aseptic Topics
The 2020 ISPE Aseptic Conference was capped off on Tuesday, 3 March, by the Interactive Regulatory Panel session, which has been a popular feature of the conference during its 29 years. The session featured a panel of seven US FDA regulators who addressed a long and varied list of questions about...
Pam Cheng
Features
Industry Leaders: Mission-Driven Leadership
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...
Wearable Devices & Biometrics Improving Efficiency in GxP Operations
Features
Wearable Devices & Biometrics Improving Efficiency in GxP Operations
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...
Regulators Address Innovations & Harmonization
Features
Regulators Address Innovations & Harmonization
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.
Update from the ISPE Regulatory Steering Council
Features
Update from the ISPE Regulatory Steering Council
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...

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WFI: A Cost Review
White Paper — Sponsored Content
WFI: A Cost Review
When it comes to producing Water for Injection (WFI), capital, operating, and maintenance costs vary and some are assumed to be more economical than others. See what we uncovered in this cost analysis of four WFI systems including alternative WFI systems versus distillation technologies.
Exploring the Myth of Inert Excipients
White Paper — Sponsored Content
Exploring the Myth of Inert Excipients
API Stability in Solid Dose Formulation: Exploring the Myth of Inert Excipients Stable active pharmaceutical ingredients (APIs) represent a critical success factor for drug formulation. This white paper examines the potential impact of poor API...
Major Advances in Magnetic Mixing Technology Permitits Broad Industrial Use
White Paper — Sponsored Content
Major Advances in Magnetic Mixing Technology Permits Broad Industrial Use
Magnetic mixing technology stands out with its many advantages compared to mechanically sealed agitators. In particular, the lower risk of contamination and the resulting cost reduction are powerful arguments for the application of magnetic agitators....
How Technology Is Helping to Deliver Critical COVID-19 Projects
White Paper — Sponsored Content
How Technology Is Helping to Deliver Critical COVID-19 Projects
The COVID-19 pandemic is creating unprecedented challenges for communities around the world. As the biopharma sector responds to the urgent need to develop vaccines and treatments, solutions providers are deploying innovative digital solutions to support...
How an MES Supports Your Business Continuity
White Paper — Sponsored Content
How an MES Supports Your Business Continuity
Business continuity relies on resilience: the ability to successfully deal with crises like COVID-19, to keep manufacturing and supportive business processes alive and to adapt to environmental changes. Pharma and biotech manufacturers who invest in...
Addressing the Evolving Information & Automation Needs of Biopharma
White Paper — Sponsored Content
Addressing the Evolving Information & Automation Needs of Biopharma
As the biopharmaceutical industry evolves and new opportunities and challenges rise, manufacturers must keep pace. For example, a dramatic increase in the amount of information that is available, in parallel with a reduction in the cost of obtaining,...

Latest Articles

Read, Learn, Innovate: Top Blog Posts from December 2020
iSpeak Blog
Read, Learn, Innovate: Top Blog Posts from December 2020
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from December 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
What Is Next in Manufacturing Injectable Sterile Products?
iSpeak Blog
What Is Next in Manufacturing Injectable Sterile Products?
As we enter the new year, this is the perfect time to make the 2021 ISPE Aseptic Conference part of your personal professional development plans. The virtual conference will allow participation from across the globe with no risk to pandemic exposure. The three-day format with shorter sessions will...
Member Spotlight – Lou Kennedy
iSpeak Blog
Member Spotlight – Lou Kennedy
Lou Kennedy, Nephron Pharmaceuticals’ President & CEO and active ISPE Member, was recently honored with a 2020 Business Leader and Public Servant of the Year Award. We spoke with Lou to learn more about her company, the many initiatives she and Nephron are undertaking on behalf of pharma, Nephron’s...
Women in Pharma®: Lessons Learned
Insights
Women in Pharma®: Lessons Learned
My parents always told me when I was growing up that I could be anything I wanted to be. They strongly steered me in the direction of engineering at North Carolina State University, so that I would be able to earn a degree that would ensure my future was my own. When I was eight years old, I was...
Emerging Leaders Editorial: Celebrate the Emerging New Year
Insights
Emerging Leaders Editorial: Celebrate the Emerging New Year
I think everyone will join me in celebrating the start of 2021! With all the challenges brought by 2020, last year also demonstrated the resilience and innovative thinking of ISPE members. With collaboration and perseverance in mind, I was delighted to begin my tenure as ISPE International Emerging...
Message from the Chair
Insights
Message from the Chair: WIP - A Key Part of ISPE Professional Career Development
I was a skeptic. When the Women in Pharma® (WIP) program started in 2016, I had previously attended several other professional women’s programs and usually left disappointed, as these programs did not provide the information I was seeking. The ISPE Women in Pharma® program is different. The program...
Read, Learn, Innovate: Top Blog Posts from November 2020
iSpeak Blog
Read, Learn, Innovate: Top Blog Posts from November 2020
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from November 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
Breaking the Document Mindset
iSpeak Blog
Breaking the Document Mindset
The Life Sciences industries adhere to strict documentation practices to prove quality and compliance. We’re all familiar with the truism “If it isn’t written down, it didn’t happen.”
FDA Commissioner Hahn: Lessons Learned From COVID-19
iSpeak Blog
FDA Commissioner Hahn: Lessons Learned From COVID-19
FDA Commissioner Stephen M. Hahn, MD, spoke about the lessons learned from COVID-19 in a presentation during the ISPE Annual Member Meeting on 5 November at the 2020 ISPE Annual Meeting & Expo. He discussed how the FDA has been responding to the pandemic, including how actions taken in response to...
Regulators Discuss Distant Assessments During and After COVID-19
iSpeak Blog
Regulators Discuss Distant Assessments During and After COVID-19
2020 ISPE Europe Annual Conference This article covers a regulatory panel discussion at the virtual 2020 ISPE Europe Annual Conference on the topic of Distant Assessments on GMP and Inspection Reliance. Driven by digitalization, these assessments help the industry and regulators manage inspection...
Be a Positive Force
iSpeak Blog
Be a Positive Force
We are constantly being influenced and we ourselves are influencers. As children, we hear the quote that “sticks and stones may break my bones, but words will never hurt me.” What people say and even what people do not say, can have a lasting impact. We are first influenced by our families and some...
Regulatory Panel Addresses COVID-19 Challenges
iSpeak Blog
Regulatory Panel Addresses COVID-19 Challenges
2020 ISPE Europe Annual Conference At the 2020 ISPE Europe Annual Conference on 16–17 September, which was a virtual conference, three regulatory panel discussions included more than 20 regulators from eight countries and the European Medicines Agency (EMA), Medicines and Healthcare Products...
What is the Impact of Article 117 on the Pharma Industry?
iSpeak Blog
What is the Impact of Article 117 on the Pharma Industry?
Article 117 of the EU Medical Device Regulation (MDR), fully applying May 26, 2021, is significantly impacting BioPharma companies. While integral drug-device combination products (such as pre-filled syringes and pre-filled injectors) are regulated as medicinal products in Europe (EU), certain...
A dance floor facility design showing static buffer tanks and minimized tubing lengths
Online Exclusives
Biopharma Facility Design: Lessons Learned on the Dance Floor
In 2014, Pharmaceutical Engineering® published an article, “Lessons Learned in the Ballroom,”Wolton, D. A., and A. Rayner. “Lessons Learned in the Ballroom.” Pharmaceutical Engineering 34, no. 4 (2014). which presented for the first time an alternative to the then-popular ballroom concept adopted...
Read, Learn, Innovate: Top Blog Posts from October 2020
iSpeak Blog
Read, Learn, Innovate: Top Blog Posts from October 2020
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from October 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
2020 ISPE Annual Meeting & Expo Opening Plenary: New Therapies, New Approaches
iSpeak Blog
2020 ISPE Annual Meeting & Expo Opening Plenary: New Therapies, New Approaches
2020 and the COVID-19 pandemic have presented tremendous challenge to the world and the pharmaceutical industry—but from the pandemic has come stepped up development of vaccines and treatments, increased urgency to address supply chain challenges, and forging ahead to develop and expand of cell and...
Figure 1: Illustration of sedimentation control in enclosed geometries using air-fi lled hydrophobic microcavities.
Technical
Passive Sedimentation Control in Containers Using Marangoni Forces
When fluid-filled containers are stored for long periods of time with negligible motion, sedimentation and gravitational settling of particles can occur. This article discusses a passive sedimentation control mechanism that is driven by Marangoni stress, which is induced in enclosed geometries when...
HVAC and Cleanroom Design: ZETA is Expanding its Service Portfolio
Sponsored Content
HVAC and Cleanroom Design: ZETA is Expanding its Service Portfolio
The highest quality and safety standards are key criteria in the planning and development of production facilities for pharmaceutical and biotech companies. However, building services engineering is no less important and demands in this field have been increasing steadily over the past few years....
Small Granulation Lines with Rapid Change
Sponsored Content
Small Granulation Lines with Rapid Change
The pilot-scale is an important stage for the pharmaceutical manufacturers, it is an indispensable intermediate step after the products have been developed in the R&D labs and before they are ready for commercial production in large volumes. Beside its...
Reducing Complexity through Digital Transformation
Sponsored Content
Reducing Complexity through Digital Transformation
The development of pharmaceutical products from the design stage to large-scale industrial production involves numerous planning steps. The volume of digital planning data increases as the project progresses. From concept design, followed by detailed engineering and 3D modelling, to electrical...

Current Issue

Pharmaceutical Engineering

January / February 2021

Women in Pharma®: Empowering Women as Industry Leaders Cover: Women in Pharma® is a place where women and men—especially those new to the industry—can access a network of mentors, role models, and educational resources to support their professional success. The widespread global interest and participation in this initiative and its events have shown that women in the pharmaceutical industry are...