Online Exclusives

This article summarizes the key findings from the 7th Pharma 4.0™ Survey, conducted in 2023. It explores the demographics of the survey respondents, maturity levels of Pharma 4.0™ adoption, enabling technologies being leveraged, anticipated benefits, and challenges encountered.

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The Zydus OSD project focused on process innovation and automation to scale up, reducing costs and turn-around times. It is for those reasons it has been recognized with an Honorable Mention for the 2024 ISPE FOYA...
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

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...

September / October 2024
PIC/S in Latin America: Harmonization of cGMP Procedures Cover: This article offers an overview of the benefits of Pharmaceutical Inspection Co...
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