翻译：Julia 来源：Julia法规翻译13.03.2018Inspectors' Aide Memoire on Process Validation - a Detailed Analysis检查员工艺验证备忘—详细分析With the Annex 15 revision, the issue of process validation became significantly more complicated. What is the authority's view on process validation nowadays? In order to reacha uniform approach, the German Central States' Authority (ZLG - Zentralstelleder Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten) hasissued a new aide memoire on process validation.随着附录15的修订，工艺验证的问题显然变得更为复杂。官方目前在工艺验证方面的观点又是怎样的呢？为了达成一致方法，德国中央药监局（ZLG）刚发布了一份工艺验证的新备忘。The 47-page document describe show the general principles of validation and QRM should be applied to p
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