Good Distribution Practice (GDP)

24 June 2024 Good Distribution Practice (GDP)

No Quick Fix: The Surprising Costs of Starting a Pharma Wholesaling Business in the Netherlands

Navigating the complex landscape of obtaining a Wholesale Distribution Authorization (WDA) license is no easy feat, especially for startups. However, cutting corners and attempting to "hack" your way into compliance c...

Jaap Koster

CEO / Senior GxP Consultant

23 February 2024 Good Distribution Practice (GDP)

What is a Wholesale and Distribution Authorization (WDA) in pharma?

WDA, or Wholesale Distribution Authorization, is crucial in the pharmaceutical industry. It's required for storing medicinal products for over 72 hours. Learn how to obtain it and navigate post-Brexit regulations for...

Jaap Koster

CEO / Senior GxP Consultant

23 February 2024 Good Manufacturing Practice (GMP) Good Distribution Practice (GDP)

How clear communication is critical in preventing human errors

This blog explores the Tenerife disaster's lessons on human error and communication, drawing parallels to the pharmaceutical industry. It emphasizes the need for clear communication, standardized protocols, and a safe...

Jaap Koster

CEO / Senior GxP Consultant

23 February 2024 Good Manufacturing Practice (GMP) Good Distribution Practice (GDP)

Conducting in-depth investigations during GMP/GDP audits

Tips for conducting in-depth GMP or GDP audits: Understand different levels of inspection-depth: absence, adherence, and adequacy. Use intellect and intuition to spot issues. Classify findings as critical, major, or m...

Jaap Koster

CEO / Senior GxP Consultant

23 February 2024 Good Manufacturing Practice (GMP) Good Distribution Practice (GDP)

The Critical Role of Proper Deviation Management

The Critical Role of Proper Deviation Management in the Pharmaceutical Industry: Explore the importance of deviation and CAPA management, including impact assessments and root cause analysis, to ensure product quality...

Jaap Koster

CEO / Senior GxP Consultant

8 February 2024 Good Distribution Practice (GDP)

GDP for Distributors of Medicinal Products Without Storage

Transporters storing medicinal products >72 hours can get a WDA (GDP license). Under 72 hours storage doesn't qualify for WDA or GDP certificate. Voluntary GDP adherence is an option for client satisfaction.

Jaap Koster

CEO / Senior GxP Consultant

8 February 2024 Good Manufacturing Practice (GMP) Good Distribution Practice (GDP)

Planned v.s. Unplanned Deviations

"Exploring the debate between Planned vs. Unplanned Deviations in GMP. Let's focus on real issues like drug shortages, not semantics.

Jaap Koster

CEO / Senior GxP Consultant

25 January 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

25 January 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