Featured Articles

Features

Recent advances in artificial intelligence (AI) have led to its widespread industrial adoption, with machine learning (ML) algorithms demonstrating advances in performance in a wide range of tasks. However, this comes with an ever-increasing complexity of the algorithms used, rendering such systems more difficult to explain.1

  • 1Samek, W., and K. R. Müller. “Towards Explainable...
Features

ISPE’s GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) (GAMP® 5 Guide, 2nd Edition) maintains the principles and framework of the first edition and updates their application in the modern world, including the increased importance of service providers, evolving approaches to software development, and expanded use of software tools and...

Features

In this article, potential Pharma 4.0™ technological solutions that can enhance continuous process verification (CPV) 4.0 are discussed. The necessary paradigm shift will allow companies to predict deviations more accurately, perform root cause analysis (RCA), ensure data integrity and GxP compliance, and ultimately be more competitive in a highly regulated industry.

Technical

Pandemic-related supply chain shortages have placed constraints on the supply of essential filters and chromatography resins. An agile regulatory pathway to implement alternative filters and resins into manufacturing is necessary to ensure the continued supply of approved biologics. To allow this in the US and potentially globally, the regulatory strategy proposed in this article is to provide...

Technical

Topical drug products and cosmetics are often manufactured in the same facility under a unified quality standard that supports the topical drug products’ performance and label claims. Cleaning is an important component of a manufacturing process, and the process life-cycle approach should be followed for cleaning validation.1

  • 1US Food and Drug Administration. US Code Title 21: Food...
InTouch

ISPE’s new Advancing Pharmaceutical Quality (APQ) Guide: Process Performance and Product Quality Monitoring System (PPPQMS) focuses on the key aspects of maintaining and establishing an effective PPPQMS. An effective PPPQMS is crucial to establishing and maintaining a state of control. It enables continual improvement and is key to proactively identifying the need for product quality and...

InTouch

The Commissioning and Qualification (C&Q) CoP was one of the first Communities of Practices to be established at ISPE. One of its founding members, Steve Wisniewski, Principal Consultant, CAI, said the Communities of Practice was formed in 2004 to identify and promote more efficient approaches that resulted in pharmaceutical facilities being fit for their intended purpose.

InTouch

The ninth ISPE Europe Annual Conference was the first in-person conference after a break of over two years due to the pandemic. For travel-related reasons, some attendees participated remotely. With 450 participants on-site and nearly 490 total attendees, the usual atmosphere of an

Features

Resounding clinical successes and maturation of extensive therapeutic pipelines have catapulted oligonucleotides from a fringe modality to therapeutic relevance in just a few short years. Oligonucleotides are a cornerstone of a burgeoning class of drugs classified as nucleic acid therapeutics. These therapies interact with DNA and RNA targets rather than traditional protein therapeutic...

Features

Digital health is transforming the health care landscape through new technologies and platforms in patient care management, conducting of clinical trials, patient data collection, and the diagnosis and treatment of disease. Emerging digital health technologies (DHTs) may improve the quality of life for patients with chronic and debilitating diseases and provide novel health care solutions for...

Features

A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally. With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Therefore, there is an increasing need to implement a harmonized regulatory infrastructure that is both flexible and predictable to provide more...

Features

Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Incorporating concepts and tools from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline, combined with structured content and data management (SCDM) and a cloud-based data exchange...

Features

Although data and knowledge are both stand-alone disciplines that need to be systematically managed, they also must have a connection. Understanding the relationship between data and knowledge management processes and how people are leveraging advances like Pharma 4.0™ combined with these processes enables quality data transition to knowledge that can help pharmaceutical companies. The authors...

Features

As the pharmaceutical industry continues to grow and evolve, a significant contributor to innovation and evolution is mergers and acquisitions (M&A). M&A can enable academic researchers and small companies to fund and commercialize innovative products. In addition, M&A can help larger organizations secure new and complementary technology and products. In the pharmaceutical...

Features

As the industry experiences significant changes to the way we do business, knowledge capture and sharing are more important now than ever before. The maturing digitalization of the biopharma industry’s business and processes is creating an increasingly data- and information-rich environment that requires more effective mechanisms for sharing data and information. The Knowledge Management team...

Features

The life cycle approach to process validation stresses the need for continued monitoring of process performance to ensure that the manufacturing process remains stable and predictable, i.e., in a state of control. This life cycle stage is known as continued process verification (CPV) or ongoing process verification (OPV).1

  • 1US Food and Drug Administration Center for Drug Evaluation...
Features

What do recipients of ISPE’s prestigious Facilities of the Year Award (FOYA) know that has helped their projects succeed? What are the lessons learned from achievements in facilities development, including forward-looking projects that encompass and inspire changes in the industry? Pharmaceutical Engineering® spoke with nine FOYA winners from recent years about the lessons they learned and...

Special Reports

In 2020, the world was grappling with how to slow the spread of the SARS-CoV-2 virus and appropriately treat people who had the COVID-19 infection without approved therapies or vaccines. In two years, there are multiple vaccines and treatments along with great knowledge about the virus—and about how the industry mobilized, partnered, and achieved tremendous strides in addressing the global...

Special Reports

Operation Warp Speed coordinated US government support of the pharmaceutical industry’s effort to develop and deliver vaccines and therapeutics across the United States to fight the COVID-19 pandemic. This article provides an inside look at the work done by this team to address the threat posed by COVID-19.

Features

During the past decade, industry has experienced a proliferation of regulatory divergence regarding the interpretation and implementation of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (and control strategies) across geographic regions. This article shares data that highlight instances where well-established ICH...

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Latest Articles

iSpeak Blog

Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are some articles to start off the new year right! We revisit a favorite topic, sustainability—and will be updating our coverage of this topic with the upcoming March-April 2023 issue of Pharmaceutical Engineering.

iSpeak Blog

It has been a long journey from the development of primarily manual aseptic processes to fully automated systems that do not require manual intervention. Looking back in history, it was a step-by-step development forward to the current contamination control strategy (CCS) many decades ago. The risk of contamination of a sterile product from the environment (room) and the people who do work in...

Insights

When I started working in the pharmaceutical industry, I was looking for ways to grow my knowledge, my community, and my skillset. When I founded the Emerging Leaders committee within the ISPE D/A/CH (Germany, Austria, and Switzerland) Affiliate, I knew I had found that way.

Insights

As we head into 2023, it is hard to believe that it has been four years since the COVID-19 pandemic started to impact our lives and transition us to a new normal. It is also amazing how much technology and innovation continued to advance in those four years to allow our industry to develop new vaccines and innovative products to meet the world’s challenges.

iSpeak Blog

Cultural Excellence is the expressed and implied ways in which an organization operates. Excellence in organizational culture is essential for delivering robust and sustained quality performance and ensuring patient-focused outcomes. Culture determines quality outcomes by affecting the organization’s ability to identify and act upon near-miss shortages, ensuring the integrity of its data,...

iSpeak Blog

ISPE’s Women in Pharma® group strives to tackle unconscious biases that limit women, and other marginalized groups, within the pharmaceutical community. Over the last few years, the group has grown to be a global force across borders, connecting industry professionals through regional and international programming, including having a presence at the 2022 ISPE Annual Meeting &...

iSpeak Blog

Multi-Use Filling Line for RTU Syringes, Vials, Cartridges and Bulk Vials - Photo courtesy of INCOG BioPharma Services


“Leading Edge, Not Bleeding Edge”

The definition of technology is “the set of knowledge, skills, experience, and techniques through which humans change, transform and use our environment in order to create tools, machines, products...

iSpeak Blog

Change from default private to default public within the company?

We are The Culture Club, a self-formed cross-COP group of individuals who came together to discuss challenges encountered as we transition quality and validation into the digital world and identify ways to influence cultural changes needed within our industry to better enable innovation. As we are not all from the...

iSpeak Blog

Excellence is everywhere, and it must be illuminated. For the fourth consecutive year, the annual ISPE Italy Affiliate Award for women in the pharmaceutical sector will be organized by the local group of ISPE Women in Pharma® (WIP). This important initiative was created to celebrate the commitment, perseverance, professionalism and competence of the women who work in this sector, qualities...

iSpeak Blog

A key challenge in life sciences is the detrimental effect of unplanned downtime and lost batches due to unanticipated equipment failure. Traditional maintenance programs are calendar or condition-based and can range from being overly conservative to reactive, leaving money on the table (over-maintenance - “just in case”), or jeopardizing productivity altogether. As described in the ISPE Good...

iSpeak Blog

As one of the founders of Cheme Engineering, Nik Krpan was instrumental in the start-up of the company. He became president of the company in 2012. Nik says that leading the company through continued growth has been an exciting aspect of his career. “We started with five people and now we have more than sixty. It’s been really rewarding to be part of a creating an environment where people can...

iSpeak Blog

By the ISPE Regulatory Team

ISPE’s regulatory volunteer groups are charged with bringing visibility and solutions to major challenges faced by the industry with regard to regulatory/quality matters, and facilitating the flow of information between ISPE members and global Health Authorities. Support for that mission was on display at the 2022 ISPE Annual Meeting and...

iSpeak Blog

As we are all aware, the COVID-19 pandemic has had a unique, world-wide effect on the pharmaceutical industry as well as health authorities. At the height of the pandemic, and continuing as it appears to wane, health authorities have not been able not carry out normal, in-person inspections of pharmaceutical manufacturing sites. However, in the ”Age of Covid,” using the Internet and associated...

iSpeak Blog

On 17 August 2022, four international regulators discussed how the Covid-19 pandemic had taught regulators to look for alternative ways of doing GMP inspections and also to rely more on each other to make determinations on the GMP status of manufacturers of medicines.

iSpeak Blog

A look through the lens of GAMP 5® Second Edition

IT Infrastructure is a broad term that encompasses both the platforms upon which business applications run, as well as the services that keep these platforms and applications running. Figure 1 below shows this landscape.

Online Exclusives

This article shows how non-supervised artificial intelligence (AI) methods can strongly support common processes in the pharmaceutical industry such as wet granulation drying. The techniques used demonstrate how continuous process optimization can be enabled and the process control strategy is permanently updated while keeping product quality under strong assurance and also increasing energy...

Current Issue

January / February 2023

Applying GAMP® Concepts to Machine Learning Cover: This article explores life-cycle activities for machine learning (ML) within regulated life sciences. It positions and contextualizes the life cycle and management of the machine learning subsystem or components within a wider system life cycle. It also gives general descriptions and guidance illustrated by a case study demonstrating a machine...