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1.1 This guide introduces key concepts and principles to assist in the appropriate selection, development and operation of continuous processing technologies for the manufacture of pharmaceutical products.
1.2 Particular consideration is given to the development and application of the appropriate scientific understanding and engineering principles that differentiate continuous manufacture from traditional batch manufacturing.
1.3 Most of the underlying concepts and principles (for example, process dynamics and process control) outlined in this guide can be applied in both Drug Substance (DS) and Drug Product (DP) processes. However it should be recognized that in Drug Substance production the emphasis may be more on chemical behavior and dynamics in a fluid phase whereas for drug product manufacture there may be a greater emphasis on the physical behavior and dynamics in a solid/powder format.
1.4 This guide is also intended to apply in both the development of a new process, or the improvement/redesign of an existing one.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
|Engelse titel||Standard Guide for Application of Continuous Processing in the Pharmaceutical Industry|