The leading journal for specialists and managers in pharmaceutical manufacturing and quality assurance
20.02.2025
Representativeness and Proactive Alert Limit Setting for Aseptic Interventions. Please read more here
Read more … Statistical Approach to Aseptic Process Simulation
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
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