PE Magazine | July / August 2024
Data Analysis of Contamination Control Strategies for Production

On 25 August 2023, the long-awaited revision to Annex 1 became effective, introducing significant regulatory changes, including the requirement of a documented contamination control strategy (CCS).

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PE Magazine | July / August 2024
Acceptable Discoloration Levels on Pharmaceutical Weld Beads

Welds used in biopharmaceutical manufacturing must meet critical criteria to maintain a defined level of purity and bioburden control. One highly debated area of concern is the level of discoloration allowable on the product contact surfaces in the welded condition and secondary finishing methods.

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iSpeak Blog | 6 September 2024
Elevate Your Career and Stay Ahead: Join Industry Leaders at the 2024 ISPE Annual Meeting & Expo

As the pharmaceutical landscape rapidly evolves, staying informed and connected with industry leaders is more crucial than ever.

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Product Development
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Quality
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Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma
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AI/ML in Regulated (GxP) Life Sciences Sectors - Project Phase: Iterative training and fine-tuning
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ISPE Pharma 4.0 Baseline Guide – Enabling Digital Business Transformation
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Digital Display Labeling in Clinical Trial Supply Chains
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Connecting ATMP Discovery to Commercial: Improving Manufacturability
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Project Definition Rating Index (PDRIx) for Manufacturing & Life Sciences Projects
Project Definition Rating Index (PDRIx) for Manufacturing & Life Sciences Projects Complimentary…
Unlocking the Power of Unified Capital Project Management for Pharma Companies
Unlocking the Power of Unified Capital Project Management for Pharma Companies Complimentary…
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Design, Install & Maintain a Pharmaceutical Compressed Air System
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Agile Pharma Manufacturing With Real-Time Scheduling & MES Integration
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July / August 2024

July / August 2024

The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular therapeutics, has driven steady investment in facilities capable of manufacturing these therapeutics at scale. Meanwhile, the...
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