Express Pharma
JULY 11, 2025
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!
Express Pharma
DECEMBER 23, 2024
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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European Pharmaceutical Review
APRIL 2, 2024
in the monographs for Water for Injection (0169) and Purified Water (0008) on 1 April 2024. on 1 January 2024. Timely implementation of the reference to USP <86> in the water for injection and purified water monographs is desired to encourage and enable the adoption of these methods for environmental monitoring purposes.
European Pharmaceutical Review
JANUARY 25, 2024
Identification threshold: 10 ppm Qualification threshold: 20 ppm The FDA’s deadline for submitting comments on its draft guidance is 26 February 2024. In the document, the following leachables thresholds were recommended – parts per million (ppm): Reporting threshold: 1 ppm.
Express Pharma
MAY 23, 2025
Organizations are expected to employ staff with expertise in specialised areas such as microbiology, radioisotope testing, and analytical method validation. As per data from the Press Information Bureau, India exported pharmaceuticals worth over 25 billion US dollars in the financial year 2023 to 2024.
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