Navigating GMP & GDP standards: Quality Assurance and process-centered design in pharma & biotech.
People want a neat definition, a tidy checklist, or a set of metrics to measure quality. But when you peel back the layers, it becomes clear that “Quality Culture” is more of a broad vision than a well-defined endpoint.
Jaap Koster
CEO / Senior GxP Consultant
Here’s an overview of key updates and programs shaping FDA’s direction in Q4 2024.
Jaap Koster
CEO / Senior GxP Consultant
The FDA's new guidance clarifies reporting requirements and risks for postapproval changes in biosimilars. PCS supports manufacturers in meeting GMP standards, focusing on quality, safety, and alignment with global re...
Jaap Koster
CEO / Senior GxP Consultant
APIC’s new guideline (v03) for Quality Agreements clarifies responsibilities, streamlines negotiations, and covers scope, OOS, and distribution. Ideal for efficient compliance and stronger collaboration between API su...
Jaap Koster
CEO / Senior GxP Consultant
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
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
EU GMP cleaning validation: PDE-based, risk-driven, tailored methods, continuous improvement.
Jaap Koster
CEO / Senior GxP Consultant
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
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
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 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
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
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
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
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 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
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 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
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
"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
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