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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; FDA/ICH 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. FDA 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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
U.S. Government PublicationsFDA/ICHQ8 U.S.FDAPAT
ICS Number Code 11.120.01 (Pharmaceutics in general)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM E2475-10(2016), Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control, ASTM International, West Conshohocken, PA, 2016, www.astm.orgBack to Top