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Now the Ministry of Health has published revised regulations in accordance with Annex M of the Drugs and Cosmetics Rules. Now the Ministry of Health has published revised regulations in accordance with Annex M of the Drugs and Cosmetics Rules.
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This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.
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