Remove 2024 Remove Method Validation Remove Packaging
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bioMérieux – Endotoxin Testing (rFC) – Decoding the future of endotoxin testing

Express Pharma

After 50 years of LAL testing, the pharmaceutical industry is transitioning to recombinant Factor C (rFC) methods. USP Chapter <86> (November 2024) eliminates the biggest barrier—method validation—making adoption faster and easier than ever. It is now important to switch to recombinant methods than ever before!

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FOPE and PharmaState Academy hosts Session 11 of the PULSE series

Express Pharma

On December 15, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 11 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on Good Practices In Quality Control. Chaudhary explained the necessity of sampling excipients and the exemption for dedicated facilities.

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FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. However, according to the FDA, this is “less of a concern” for products, such as biological products, that are packaged in glass containers.