ABSTRACT
In drug research and development, pharmaceutical validations are implemented to ensure that the drug product under investigation meet specifications for identity, strength, quality, purity, stability and reproducibility of the drug product. Basically, pharmaceutical validations include assay validation of analytical methods and process validation of manufacturing processes. Note that pharmaceutical validation started in the early 1970s with assay validation (Bergum and Utter, 2000). However, most of the FDA’s attention was directed toward the validation of sterile processes of injectable products. In early 1980s, the FDA began to focus on the validation of nonsterile processes. The purpose of the validation of an analytical method or a testing procedure is to assure the accuracy and reliability of the test results obtained from the analytical method or the testing procedure. The objective of the validation of a manufacturing process is to ensure that the manufacturing process does what it purports to do. A validated process assures that the final product has a high probability of meeting the standards for the identity, strength, quality, purity, stability, and reproducibility of the drug product.
