Mar 4, 2017 by admin in PHARMACYComments Off on Notes
1Title 21 Code of Federal Regulations Parts 210 and 211, 2015. 2Guideline on General Principles of Process Val, FDA, 1987. 3Guidance for Industry Process Validation: General Principles and Practices, FDA,…
Mar 4, 2017 by admin in PHARMACYComments Off on Products
Figure 1.3 CPV plan for legacy products. Source: PDA TR60 with permission.14 In order to bring current processes into line with the current guideline the following steps can be taken….