Navigating GMP & GDP standards: Quality Assurance and process-centered design in pharma & biotech.
This blog emphasizes the importance of clear, concise, and practical batch records to avoid operator errors. The article highlights the challenges posed by overly lengthy or outdated batch records, suggesting a need f...
Jaap Koster
CEO / Senior GxP Consultant
The blog post suggests a structured approach to analyze and address these errors, including understanding human behavior and creating a blame-free culture. It underlines the importance of proactive solutions over reac...
Jaap Koster
CEO / Senior GxP Consultant
A blog post on the “Clothier Report”. This report was commissionned by the Secretary of State for Social Services of the United Kingdom in March of 1972. The report is named after it’s chairman; C. M. Clothier.
Jaap Koster
CEO / Senior GxP Consultant
Data Integrity ensures data's accuracy and consistency over its lifecycle, crucial in pharmaceuticals per EU GMP. ALCOA summarizes key principles for data recording. ALCOA+ extends with four more principles for a comp...
Jaap Koster
CEO / Senior GxP Consultant
Download our training brochure for 2025 by clicking this link