The Importance of ‘Good’ Measurements on Industrial Manufacturing Efficiency and Profit

Abstract

Assessment and assurance of quality within the field of pharmaceutical manufacture is established by the development of appropriate specifications for raw materials and products. The importance of suitable specifications will first be established and examples will be given of the development of a typical specification for a pharmaceutical drug substance. This will include discussion of the types of parameters which need to be controlled and an indication of the numerical values or ranges expected for most modem materials. The analytical methodology which needs to be applied to demonstrate compliance (or otherwise) with the specification will be discussed, along with the implications of method performance necessary in order to distinguish between variations in product quality and simple analytical variability.

A workshop session will also be included which will allow students to simulate the typical discussions which might take place in any large multi-national pharmaceutical organisation when establishing specification ranges or values for a modern drug substance based on a review of batch data generated during the development and early manufacture of the drug.

As a result, students will understand the importance of the control which appropriate specifications bring, the implications of the level of analytical method performance required and the combination of good science and pragmatism used by industry in developing such specifications and methodology for assurance of the quality of modem pharmaceutical drug substances and products.