Blog

January 25, 2024 Good Manufacturing Practice (GMP)

Foolproof Batch Records - The Process Approach

Well-designed batch records are crucial for efficient production, complying with regulations, and promoting data integrity.

Jaap Koster

CEO / Senior GxP Consultant

January 25, 2024 Good Manufacturing Practice (GMP)

Foolproof Batch Records - Introduction

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 The article highlights the challenges posed by overly lengthy or outdated batch records, suggesting a need f...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

January 25, 2024 Good Manufacturing Practice (GMP) Good Distribution Practice (GDP)

Reduce Human Errors in the Pharmaceutical Industry

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

November 1, 2023 Good Manufacturing Practice (GMP)

The origins of robust pharmaceutical quality: Contaminated Infusion Fluids

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

October 30, 2023 Good Manufacturing Practice (GMP)

The difference between ALCOA and ALCOA+ (plus)

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