WHO TRS 904
WHO TRS 904 underscores a holistic QMS approach that weaves risk assessment, training, CAPA, and management oversight into one cohesive tapestry.
Jaap Koster
CEO / Senior GxP Consultant
Blog
Navigating GMP & GDP standards: Quality Assurance and process-centered design in pharma & biotech.
EudraLex, EU GMP, and the European Regulatory Framework
This post explains how the European Legislative framework for the manufacturing of medicine operates, how licensing works and what the main differences are between the European and other major GMP frameworks are.
Jaap Koster
CEO / Senior GxP Consultant
Navigating the Intricacies of EU GMP-Compliant Cleaning Validation
EU GMP cleaning validation: PDE-based, risk-driven, tailored methods, continuous improvement.
Jaap Koster
CEO / Senior GxP Consultant
Balancing Time, Money, and Quality in the Pharmaceutical Industry
Balancing time, money, and quality is crucial in pharma. Leaders must understand each other's challenges to prevent silos and enhance cooperation. Supporting departments should foster mutual understanding to maintain...
Jaap Koster
CEO / Senior GxP Consultant
Out of Specification (OOS) Testing: A Comprehensive Guide for Pharmaceutical Professionals
Handling Out of Specification (OOS) results effectively is a challenge. Despite rigorous processes and controls, OOS results can and do occur. Understanding what they are, why they matter, and how to manage them is es...
Jaap Koster
CEO / Senior GxP Consultant
Ten Common Misconceptions in GDP Implementation Clarified
This blog post addresses 10 common misconceptions in implementing Good Distribution Practice (GDP) within the pharmaceutical supply chain.
Jaap Koster
CEO / Senior GxP Consultant
The Effort Paradox in Pharmaceutical Manufacturing
The Effort Paradox serves as a reminder that knowing isn't the same as doing. In the pharmaceutical industry, where the stakes are high, overcoming this paradox is essential.
Jaap Koster
CEO / Senior GxP Consultant
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
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
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
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
The origins of robust pharmaceutical quality: Elixir Sulfanilamide
The Elixir Sulfanilamide disaster was a tragic event that occurred in 1937, resulting in the deaths of over 100 people, many of them children.
Jaap Koster
CEO / Senior GxP Consultant
What is a Manufacturing and Import Authorization in pharma?
Learn about Manufacturing and Import Authorizations (MIAs) in the pharmaceutical industry, essential for importing or manufacturing medicines in the EU.
Jaap Koster
CEO / Senior GxP Consultant
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
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
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
The Ten Golden Rules of GMP
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
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
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
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