Navigating GMP & GDP standards: Quality Assurance and process-centered design in pharma & biotech.
What is GMP? The WHO defines GMP as preventing errors that can't be eliminated through QC of the finished product. Learn about the ten golden rules of GMP.
Jaap Koster
CEO / Senior GxP Consultant
Working in a GMP cleanroom is challenging. Qualifying aseptic operators requires experience, training, and ongoing monitoring. Gowning, monitoring and behavior are crucial.
Jaap Koster
CEO / Senior GxP Consultant
Avoid common pitfalls in human error handling. Duct tape solutions and excessive procedures don't work. Understand the cause and design error-proof systems.
Jaap Koster
CEO / Senior GxP Consultant
Creating perfect GMP Batch Records can be challenging due to human factors and company culture. Establishing a safe environment for employees to report errors and leading by example are crucial for success.
Jaap Koster
CEO / Senior GxP Consultant
Well-designed batch records are crucial for efficient production, complying with regulations, and promoting data integrity.
Jaap Koster
CEO / Senior GxP Consultant
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 The article highlights the challenges posed by overly lengthy or outdated batch records, suggesting a need f...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
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