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EU Issues Plans For Significant Changes To Manufacturing Standards For Sterile Medicines

 
• By Vibha Sharma

Long-awaited plans to change the EU guideline on manufacturing standards for sterile medicinal products are out for consultation. The proposals were drafted in cooperation with the World Health Organization and the international pharmaceutical inspectorate group, PIC/S, to ensure global alignment of standards.

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Revised GMP Standards For Sterile Drugs Will Promote Adoption Of New Technologies • Source: Shutterstock

The European Commission is inviting stakeholder feedback on its proposal to make significant changes to the EU good manufacturing practice guideline in relation to sterile medicinal products. Among other things, the revised guideline includes new environmental monitoring standards for cleanrooms.

The guideline – more widely known as Annex 1 of EudraLex Volume 4 – is being updated to introduce the principles of quality risk management to allow manufacturers of sterile medicinal products to adopt new technologies and innovative processes

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