FDA - New Process Validation Guidance Document

• FDA GMP QSR cGMP Training - recommended online GMP training courses by SkillsPlus International Inc.

The FDA just published this, FDA - Guidance for Industry - Process Validation: General Principles and Practices (pdf).

In a nutshell, the CGMP regulations require that manufacturing processes be designed and controlled to assure that in-process materials and the finished product meet predetermined quality requirements and do so consistently and reliably.

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