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Manufacturing Safety Regulation

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

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Executive Summary

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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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