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[Press Release] Benchmark Products Joins Rx360 to Enhance Quality and Supply Chain Security for Pharmaceutical Manufacturers

[Press Release] Benchmark Products Joins Rx360 to Enhance Quality and Supply Chain Security for Pharmaceutical Manufacturers

Benchmark Products is proud to announce its membership in Rx360, a global consortium of pharmaceutical companies, suppliers, and service providers, dedicated to advancing pharmaceutical supply chain security and quality.

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Get Ready for Annex 1: The Importance of Compliance and How the Annex 1 Checklist Can Help You Get There

Get Ready for Annex 1: The Importance of Compliance and How the Annex 1 Checklist Can Help You Get There

The Annex 1 checklist is a helpful tool for life science manufacturers to ensure that their sterile manufacturing facilities are compliant with the latest regulations. With the new Annex 1 guidelines set to take effect in August 2023, it is more important than ever to ensure that your facility is up to date and in compliance.

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Fighting Fungi: Preventing Mold Contamination in Sterile Manufacturing Facilities

Fighting Fungi: Preventing Mold Contamination in Sterile Manufacturing Facilities

Not only does mold pose a risk to patient safety, but it can also result in product recalls, financial and reputational damage, and regulatory consequences. However, by using the right preventative cleaning and disinfecting products and procedures, manufacturers can significantly reduce the risk of mold contamination in sterile environments.

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[Podcast] How Life Science Manufacturers Can Successfully Adapt to Change

[Podcast] How Life Science Manufacturers Can Successfully Adapt to Change

In this episode of Exceeding Your Benchmark, Ashley Harp, Lead Process Engineer at CRB, talks about the challenges of pharmaceutical manufacturing adapting to rapid innovation of new therapies and various options to meet demand.

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[Podcast] How Can Cell & Gene Manufacturers Scale to Meet Demand?

[Podcast] How Can Cell & Gene Manufacturers Scale to Meet Demand?

In this episode of Exceeding Your Benchmark, Sumit Verma, Senior Vice President Global Strategic Manufacturing at Iovance Biotherapeutics, talks about the challenges faced by new biopharma startups and how cell and gene manufacturers can scale to meet demand.

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[Podcast] What Updated Annex 1 Regulations Mean for Sterile Manufacturing Companies in 2023

[Podcast] What Updated Annex 1 Regulations Mean for Sterile Manufacturing Companies in 2023

Podcast Host Gabrielle Bejarano talked to Chris White, who is the Global Head of GMP at Adamas Consulting, about what’s new and different in Annex 1, and how sterile manufacturing companies and facilities can meet the regulations by the summer of 2023.

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How to Prevent Endotoxin Contamination in Sterile Pharmaceutical Manufacturing

How to Prevent Endotoxin Contamination in Sterile Pharmaceutical Manufacturing

In pharmaceutical manufacturing, the presence of endotoxin poses a risk to final product quality and patient safety. This article will discuss what endotoxins are, how they can be detected, and how you can prevent contamination.

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3 Crucial Factors to Achieve Annex 1 Compliance

3 Crucial Factors to Achieve Annex 1 Compliance

On August 25th 2022, the FDA alongside EMA jointly released its new Annex 1 regulations for sterile drug manufacturing processes, monitoring, quality control, and more. The revision has been 14 years in the making, and largely overhauls the original 2008 good manufacturing practices with the aim of reflecting the changes of evolving manufacturing processes. The new regulations take effect on August…

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Annex 1: How Will the Revisions Effect Compliance of Your Cleanroom Facilities?

Annex 1: How Will the Revisions Effect Compliance of Your Cleanroom Facilities?

After several years of delays, the EU and FDA are now doubling down on their efforts to force drug manufacturers to comply with Annex 1…

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