The leading journal for specialists and managers in pharmaceutical manufacturing and quality assurance
20.02.2025
The USP and Ph. Eur. have recently issued several (draft) monographs for cannabis flower and cannabidiol (CBD). Please read more here
Read more … New Quality Standards for Medical Cannabis and CBD
Contamination control for both sterile and non-sterile products. Please read more here
Read more … The Whole Picture: Why Every Factor Counts in Contamination Investigations
The risks, responsibilities and opportunities of Single-Use Systems. Please read more here
Read more … Impact of EU GMP Annex 1 on the Adoption of Single-Use Systems – Exploring the Integrity Challenges
I look at the upcoming GMP PharmaCongress and GMP PharmaTechnica Expo of 2025. Please read more here
Read more … PharmaCongress 2025 - Not only, but also Annex 1
19.02.2025
This article summarizes some highlights in GMP from 2024 and an outlook at 2025. Please read more here
Read more … GMP Update 2024/2025
27.10.2024
Read more … Real-World Data (RWD) and Real-World Evidence (RWE) to Support Medicinal Product Development
Addresssing the critical Pillars of Annex 1 Compliance. Please read more here
Read more … Product, Process, People
Six years after the six-years Valsartan scandal. Has the knowledge gained been comprehensively and critically appraised? Please read more here
Read more … Valsartan
Example: Outsourced Cleaning. Please read more here
Read more … Handling external Personnel in the GMP Environment
Release Testing of the Finished Product. Please read more here
Read more … GMP Hot Spots as seen in the Warning Letters
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