ASTM E2476-16
Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
- Standard No.
- ASTM E2476-16
- Release Date
- 2016
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM E2476-22
- Latest
- ASTM E2476-22
- Scope
- 1.1 This document provides guidance on the assessment of risks to product quality within and related to PAT processes in the pharmaceutical industry. It addresses those risks to product quality arising from, associated with, identified by, or modified by the implementation of PAT in pharmaceutical development and manufacturing for primary, secondary, and biotech sectors of the industry. It does not replace those assessments of risk currently undertaken by pharmaceutical companies, but is, rather, an additional component focused specifically upon the evaluation and design of PAT processes. See Practice E2474, Guide E2500, and ICH Q8. 1 This guide is under the jurisdiction of ASTM Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility of Subcommittee E55.01 on Process Understanding and PAT System Management, Implementation and Practice. Current edition approved Nov. 1, 2016. Published November 2016. Originally approved in 2009. Last previous edition approved in 2009 as E2476 – 09. DOI: 10.1520/E2476-16. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States 1 1.2 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. Note that safety in this context refers to operational and operator safety, not to patient safety.
ASTM E2476-16 Referenced Document
- ASTM E2363 Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry*， 2023-01-01 Update
- ASTM E2474 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology*， 2024-04-22 Update
- ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment*， 2020-10-01 Update
- ISO 22000 Food safety management systems*， 2024-02-01 Update
ASTM E2476-16 history
- 2022 ASTM E2476-22 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
- 2016 ASTM E2476-16 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
- 2009 ASTM E2476-09 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
