Blog

January 25, 2024 Good Manufacturing Practice (GMP)

Qualification of Aseptic Operators in GMP Environments

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

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

Avoiding The Three Common Mistakes in Solving Human Errors

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

January 25, 2024 Good Manufacturing Practice (GMP)

Foolproof Batch Records – Quality Culture Approach

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

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 The article highlights the challenges posed by overly lengthy or outdated batch records, suggesting a need f...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