In an era where advanced therapy medicinal products (ATMPs) are revolutionizing healthcare, the 2024 ISPE Pharma 4.0™ and Annex 1 Conference, taking place 10-11 December in Rome, Italy, and...

In this blog post, Rebecca Roscher – Project Manager at Bayer AG (Supply Center Grenzach) – shares how she rose from an ISPE student member to an Emerging Leader Representative, Ex-Officio, on the 2024-2025 ISPE International Board of Directors.

The 2025 Mentor ISPE program promises to be a transformative year filled with growth, collaboration, and valuable learning opportunities for both mentors and mentees. As ISPE mentors and mentees embark on this journey, they’ll have the chance to build meaningful professional relationships, gain fresh insights, and strengthen skills through guided support and shared experiences. Whether ISPE...

The 2024 ISPE International Honor Awards were presented at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida, in October. These awards provide the opportunity for the ISPE community to recognize and celebrate the dedicated professionals who volunteer countless hours to support ISPE and its mission. This award was presented to the family of Antonio Moreira, PhD, to posthumously...

With over 23 years industrial hands-on experience in establishing and managing quality management systems within the pre-clinical, clinical and pharmaceutical as well as medical device manufacturing industries, Mei Ping Lee, who goes by Mae, is currently the Quality Assurance Manager at Winwa Medical Sendirian Berhad, Malaysia, a pharmaceutical and complementary products manufacturer and...

The pharmaceutical industry is in the middle of a transformative shift, driven by the dual forces of Pharma 4.0™ and the updated Annex 1 guidelines. These changes are introducing innovations that not only enhance the quality and safety of sterile manufacturing but also leverage new technologies to optimize efficiency and compliance. The

The use of digital information in clinical trials has evolved and expanded rapidly in recent years, raising concerns about data integrity, patient safety, and patient privacy, while also prompting new requirements by regulatory bodies. In response, ISPE has released the

The 2024 ISPE Annual Meeting & Expo, taking place 13 – 16 October in Orlando, Florida, USA, and virtually, stands out as a key event in the pharmaceutical industry. Known for its rich educational offerings, the annual event serves as a dynamic platform where professionals gather...

The proliferation of digital tools available in the pharmaceutical industry, including artificial intelligence (AI) and machine learning (ML), is revolutionizing drug discovery and manufacturing processes.

Think of implementing a digital validation tool (DVT) as being similar to building a new house. There are decisions that need to be made before starting to build a house:

The pharmaceutical industry is on the verge of a profound transformation, driven by the digital advancements of Pharma 4.0™. This shift is set to redefine the design and construction of interconnected facilities, streamlining operations and optimizing production like never before. At this year's

This blog post will discuss the relationship between large systems that manage records at the multi-batch, multi-site level of operation and the data integrity of those records. There are several aspects to consider and they are specific to this type of environment. <

Takeda Austria GmbH has been recognized as the 2024 ISPE Facility of the Year Awards (FOYA) Category Winner for Operations.

In the ever-evolving landscape of the pharmaceutical industry, staying ahead of the curve is not just an advantage—it's a necessity. With rapid advancements in technology, regulatory shifts, and emerging global challenges, professionals need a platform to learn, network, and innovate. This year's

Supply resiliency for pharmaceutical manufacturing has been a topic of increasing interest to global stakeholders (Figure 1), resulting in widespread attention and many perspectives on how to improve drug shortages and associated vulnerabilities in the drug supply chain. At its core, supply resiliency is the ability for a manufacturer to have the agility, capacity, quality maturity, and risk...

Building on last year’s successful collaboration, AstraZeneca is once again stepping up to support ISPE’s Women in Pharma^® by sponsoring Women in Pharma® Monday Night Networking Event at the

In the rapidly evolving pharmaceutical landscape, artificial intelligence (AI) has been hailed as having the potential to revolutionize everything from drug discovery to pharmaceutical manufacturing. As the industry seeks to further explore and invest in potential opportunities for improvement and growth with AI, pursuing a thoughtful and informed approach to AI strategy planning becomes...

Any validation or quality professional working in life sciences or other highly regulated industries must possess a thorough understanding of data integrity, its regulatory requirements, and the acronym commonly associated with it: ALCOA. Even those who consider themselves well-versed in the subject may be surprised to encounter an emerging concept: ALCOA++. This expanded framework (denoted by...