The American Society for Testing and Materials (ASTM) has released ASTM E2475 - 10(2016) Standard Guide for Process Understanding Related to Pharmaceutical Manufacturing and Control on September 13, 2016.
This standard guide establishes framework and context for the process of understanding pharmaceutical manufacturing, using quality by design (QbD) (Juran, 1992;2 FDA/ICH Q8).
This guide applies to other active pharmaceutical ingredient (API) and to drug product (DP) manufacturing.
This standard is developed based on the following:
- E456 Terminology Relating to Quality and Statistics
- E2281 Practice for Process Capability and Performance Measurement
- E2474 Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
- E2617 Practice for Validation of Empirically Derived Multivariate Calibrations