Calibration and validation handwritten notes

Save (0)



UNIT-3 Calibration and validation-as per ICH and USFDA guidelines Calibration of following Instruments Electronic balance, UV-Visible spectrophotometer, IR spectrophotome ter, 5.1 INTRODUCTION Process validation is a requirement of current Good Manufacturing Practices (GMPs) for finished pharmaceuticals and of the GMP regulations for medical devices and therefore, applies to the manufacture of both drug products and medical devices. According to USP, “Validation is the process of providing documented evidence that the method does what it is intended to do”. In other words the process of method validation ensures that the proposed analytical methodology is accurate, specific, reproducible and ugged for its intended use. According to the USFDA Guidelines on General Principles of Process Validation, process validation is defned, “as establishing documented evidence, which provides a high degree of assurance, that a specific process will consistently produce a product meeting its Predetermined specifications and quality characteristics.” The process for making a drug product consists of a series (Alow diagram in logically defined steps) of unit operations modules) that result in the manufacture of the finished pharmaceutical. The elements Ouality control system” and “Validation and process Validation of hedule M to the drugs and cosmetic ules provide as under. 5,1 Scan ned with GGMScGNner