Process Control insurance is based on acurate and statistically valid measurements of the control variable, be it a process parameter or a quality attribute. The measurement or observation is dependent on a representative sample or samples taken and measured in an appropriate time scale. This standard aims to develop meaningful and statistically valid sampling practices and procedures that facilitate development and manufacture of quality pharmaceutical products.
Keywordssampling, process control, pharmaceuticals, measurement
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top