3个回答
希望可以帮到你:
1. CFDI 2023.03 药品共线生产质量风险管理指南
2. FDA 2013.04 Guidance for Industry Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination
3. EMA 2014 Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
4. EMA 2018 Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’
5. EU GMP Part1 有相关章节
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