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ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.  

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iSpeak Blog

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...

iSpeak Blog

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

iSpeak Blog

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

iSpeak Blog

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. <

iSpeak Blog

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...

iSpeak Blog

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...

iSpeak Blog

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...

iSpeak Blog

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...