Validation protocols, Good Manufacturing Practice

We can recognize three distinct but interdependent, effective standards 1) USP-NF standards, 2) current good manufacturing practices, and 3) in-house quality assurance or process validation protocols. The three programs are different but have the same objective drug product quality. The official standards are developed to be meaningful in this multiple context. In recent years, a similar array has occurred in most developed nations, and this is rightfully seen as a measure of success. 

Important protocols for method validation in the literature have been derived, amongst others, from the Current Good Manufacturing Practice, Code of Federal Regulations, Food and Drug Administration, National Drug Administration, the United States Pharmacopoeia Convention, the American Public Health Association and the International Conference on Harmonization. 

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