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ICH issued Step 2 of the Pharmaceutical Quality System Guideline Q10
The new ICH Guideline Q10 has combined different guides for Quality Systems into one document.
This guideline was developed based on the following documents to achieve a global harmonization for the requirements of a modern quality system.
ISO 9000: "Quality Management Systems"
ISO 9001: 2000: "Quality Management Systems"
ISO 9004: "Quality Management Systems"
Eudralex Volume 4: "Medicinal Product for Human and Veterinary Use: Good Manufacturing Practice"
ICH Q7a: "Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients"
US FDA: "Draft Guidance for Industry Concerning Quality Systems Approach to Pharmaceutical current Good Manufacturing Practice Regulations"
ISO 13485: 2003 Medical devices -- Quality management systems
You can read the full guideline on the ICH web page by "clicking here"
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