ASTM E2475-10(2016)
Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
- Standard No.
- ASTM E2475-10(2016)
- Release Date
- 2010
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM E2475-23
- Latest
- ASTM E2475-23
- Scope
1.1 The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using quality by design (QbD) (Juran, 1992;2 FDA/ICH8201;Q8). The framework is applicable to both active pharmaceutical ingredient (API) and to drug product (DP) manufacturing. High (detailed) level process understanding can be used to facilitate production of product which consistently meets required specifications. It can also play a key role in continuous process improvement efforts.
1.2 Process Analytical Technology (PAT) is one element that can be used for achieving control over those inputs determined to be critical to a process. It is important for the reader to recognize that PAT is defined as:
“…a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in process materials and processes, with the goal of ensuring final product quality. It is important to note that the term analytical in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner. The goal of PAT is to enhance understanding and control the manufacturing process…” (U.S.8201;FDA8201;PAT)
1.3 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.
ASTM E2475-10(2016) Referenced Document
- ASTM E2281 Standard Practice for Process Capability and Performance Measurement
- ASTM E2474 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology*， 2024-04-20 Update
- ASTM E2617 Standard Practice for Validation of Empirically Derived Multivariate Calibrations
- ASTM E456 Standard Terminology for Relating to Quality and Statistics
ASTM E2475-10(2016) history
- 2023 ASTM E2475-23 Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
- 2010 ASTM E2475-10(2016) Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
- 2010 ASTM E2475-10 Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
