WHO publishes New Version of Guide regarding the Principles of GMP
Recommendation
10/11 February 2026
Heidelberg, Germany
Medicinal Products/Drugs meet Medical Devices
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
The draft for comment of this superordinated Guideline was already published in the middle of 2013 (we reported). Since then, nothing has fundamentally changed. Only changes to the following chapters have been made:
1. Pharmaceutical quality system (formerly "quality assurance")
2. Good Manufacturing practices for pharmaceutical products
7. Contract production, analysis and other activities
17. Good practices in quality control
Compared to the draft from 2013, the new document contains an extended description of the pharmaceutical quality system. In Chapter 1, the ultimate responsibility of senior management has been strongly emphasized. Likewise, the aspect of qualification has been complemented. In Chapter 2, the required review of processes has been extended to the scientific aspect (so far only review based on experience only).
The Guideline "Good Manufacturing Practices for Pharmaceutical Products: Main Principles" has been published as Annex 2 of the Technical Report 986.
Related GMP News
15.12.2025EU Reaches Landmark on Reform of Pharmaceutical Legislation
12.11.2025GMP for Veterinary Products: Implementing Regulations published
22.10.2025Content Review of the Audit Trail Review
15.10.2025Executing the Audit Trail Review
08.10.2025Risk-based Determination of the Scope and Frequency of Audit Trail Reviews