Notes

Mar 4, 2017 by in PHARMACY Comments 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,…

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of PV

Mar 4, 2017 by in PHARMACY Comments Off on of PV

Figure 1.4 Summary of activities for CGMP compliance. Source: PDA TR60 with permission.14

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Products

Mar 4, 2017 by in PHARMACY Comments 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….

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