It has been recognised for many years that the sampling and testing of materials does not by itself assure product quality. Any testing performed must be part of a comprehensive Pharmaceutical Quality System, including QA and GMP, and it must be correctly implemented and controlled.
This module reviews the principal qualitative and quantitative analytical methods in common use, the principles of method selection and validation. It also includes, sampling plans, physical and organoleptic testing, stability testing and the significance of degradation, contamination and adulteration of pharmaceutical materials. Importantly, it also includes the interpretation of analytical data including non-conforming results and stresses the importance of how these need to be managed. All activities are discussed and explained within the confines of Good Quality Control Laboratory Practice and applicable regulatory guidelines.
This module reviews the principal qualitative and quantitative analytical methods in common use, the principles of method selection and validation. It also includes, sampling plans, physical and organoleptic testing, stability testing and the significance of degradation, contamination and adulteration of pharmaceutical materials. Importantly, it also includes the interpretation of analytical data including non-conforming results and stresses the importance of how these need to be managed. All activities are discussed and explained within the confines of Good Quality Control Laboratory Practice and applicable regulatory guidelines.
