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...

At the 2024 ISPE Biotechnology Conference, which took place on 17 - 18 June in Boston, Massachusetts, USA, ISPE Women in Pharma^® hosted a compelling panel discussion titled "Beyond Boundaries: AI-Driven Efficiency in Modern Workspaces." The session -- designed and led...

The 2024 ISPE Annual Meeting & Expo, taking place 13 – 16 October in Orlando, Florida, USA and virtually is set to be a landmark gathering for pharmaceutical engineering professionals. This year’s meeting is packed with workshops designed to equip industry...

ISPE Women in Pharma^®’s dedication to diversity, equity, and Inclusion isn't just about aspirations: it’s about action. Mentor ISPE, launched in 2023 by members for members, is a testament to this commitment. Over the past two years, more than 700 professionals from around the world have joined ISPE on this journey, and as Mentor ISPE approaches its third year, the team invites ISPE...

The 2024 ISPE Annual Meeting & Expo is the pharmaceutical industry’s gateway to discovering the latest trends, technologies, and best practices shaping the future of pharmaceutical engineering. This year, 13-16 October in Orlando, Florida, USA, ISPE has curated a diverse...

Miriam Kremer-van der Kamp is the Business Developer at VILS Switzerland GmbH and an active ISPE member with the ISPE Germany/Austria/Switzerland (DACH) Affiliate, ISPE Women in Pharma, and ISPE Emerging Leaders. In this interview, conducted by Edyna Miguez, Membership Growth Manager at ISPE, Kremer-van der Kamp weighs in on why she joined ISPE, the benefits she’s experienced thus far, and...

What do the EU GMP Annex 1 and the ISPE Baseline Guide Volume 8: Pharma 4.0™ (First Edition) have to do with each other?

At the 2024 ISPE Biotechnology Conference, held in Boston, Massachusetts, USA, in June, Sharmista Chatterjee, PhD, director of the US Food and Drug Administration’s (US FDA) Division of Pharmaceutical Manufacturing Assessment III, Office of Pharmaceutical Quality (OPQ), Center...

As the global pharmaceutical industry continues to evolve, staying ahead of the curve is more crucial than ever. The 2024 ISPE Annual Meeting & Expo, set to take place from 13 - 16 October in Orlando, Florida, USA and virtually is the opportunity to connect, collaborate, and lead in this dynamic landscape. This year’s event promises to be the most impactful yet, offering an unparalleled...

As the pharmaceutical landscape rapidly evolves, staying informed and connected with industry leaders is more crucial than ever. The 2024 ISPE Annual Meeting & Expo, 13-16 October in Orlando, Florida, USA and virtually offers a unique platform to gain insights, enhance your professional development, and network with the brightest minds in the field. This event is designed to empower...

Pharmaceutical Engineering® (PE) is delighted to announce the finalists for the 2023 Roger F. Sherwood Article of the Year Award. The articles were selected by judges from 39 feature and technical articles published in PE during calendar year 2023 (Volume 43).

Pharma Manufacturing Co., Ltd. has been awarded the 2024 ISPE FOYA Category Winner for Social Impact. This recognition highlights their exceptional work on the UK4 project, a biological drug substance manufacturing facility designed and built under the...