Pharma newsletter May 2024
Dear reader,
The pharmaceutical industry is a continuously evolving environment. New drugs are being developed, and more cell and gene therapies are being commercialized. Even hospital pharmacies are becoming more regulated, for example, by the new PIC/S standard for pharmacy preparations. Therefore, new facilities need to be constructed or existing facilities need to be revamped, taking into account the specific needs of the production process. A well-considered plan needs to be made. Which cleanroom grade will be required? Will a continuous manufacturing process be possible? How much of the process can be automated? All these choices will also determine the complexity of getting your facility GMP ready.
This GMP readiness must be considered from the early stages of the project. Are the requirements well defined? Which steps in my process are the most critical? Can we leverage our efforts during the commissioning phase (FAT/SAT) into the qualification stage? These factors can all impact your project timelines and cost significantly.
When setting up the project plan, keep in mind the sequence of activities: facility and utility qualifications, equipment qualification, SCADA qualification, cleaning, sterilization, and process validation (if applicable). Don’t forget your IPC and release testing lab, the lab equipment qualification, and the analytical method validation. Have you thought about using paperless validation software to increase the efficiency and flexibility of your project?
I hope these insights provide valuable guidance and some food for thought. Now, let's dive into this new edition of our monthly pharma newsletter, packed with the latest updates, content, and insights shaping the future of healthcare.?
Happy reading!
REGULATORY UPDATE IN PHARMA
Must-read tip ??
Learn about nitrosamine impurities in medicinal products, their causes, regulatory guidance, and strategies for risk evaluation and mitigation in this blog post.
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The One-Vigilance Strategic Roadmap to corporate excellence?
The objective of this whitepaper is to introduce the concept of One-Vigilance ? within the context of the current drug safety landscape.
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GAMP 5 Software Validation Approach for GMP, GCP and GLP regulations?
This whitepaper will first give you insights into which guidelines are applicable, in which setting, and how to comply with these guidelines. A comparison will be made between the different fields and how GAMP5 can be used to comply with each of these regulatory frameworks.
UPCOMING WEBINAR (IN SPANISH)
This Spanish webinar dives deep into the intricate relationship between quality standards and pharmacovigilance objectives within the pharmaceutical industry. We'll explore key strategies for safety departments to successfully navigate audits and inspections, ensuring both medicine quality and adherence to rigorous pharmacovigilance standards.
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Don't miss out on this innovative Safety & Pharmacovigilance event. Connect with the QbD Group as we unlock new possibilities and address key challenges for safety professionals through collaboration, creativity, and excellence. See you at booth 92!
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