1、Designation:E262919Standard Guide forVerification of Process Analytical Technology(PAT)EnabledControl Systems1This standard is issued under the fixed designation E2629;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last
2、revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide describes the verification of process analyti-cal technology(PAT)enabled control systems using a science-and risk-bas
3、ed approach.It establishes principles for determin-ing the scope and extent of verification activities necessary toensure that the PAT-enabled control system is fit for purpose,properly implemented,and functions as expected.1.2 In this guide,a PAT-enabled control system is consid-ered to be the syst
4、em that adjusts the manufacturing processusing timely measurements(that is,during processing)ofattributes of raw and in-process materials to determine re-sponses that assure the process remains within specifiedboundaries and minimizes variability in the output material.The overall aim of the PAT-ena
5、bled control system is to ensureproduct quality.The PAT-enabled control system of a manu-facturing process provides the capability to determine thecurrent status of the process and drive the process to ensure theoutput material has the desired quality characteristics.Thecontrol system should be able
6、 to respond to process variationsin a timely manner,providing corrections that ensure that theprocess follows the desired process trajectory to reach thedesired outcome.PAT-enabled control systems may use pro-cess models based on first principles understanding or empiri-cal models derived from exper
7、imental investigations or both.In addition to automated controls,a PAT-enabled controlsystem may include components where there is manual inter-vention.1.3 Principles described in this guide may be appliedregardless of the complexity or scale of the PAT-enabledcontrol system or whether applied to ba
8、tch or continuousprocessing,or both.The intention of this standard is to describeand support the implementation of a PAT enabled ControlStrategy,as described in ICH Q8(R2).1.4 The principles described in this guide are applicable toa PAT-enabled control system and also to its componentsubsystems.Thi
9、s guide does not cover the requirements forcontinuous quality verification of the overall process,whichare covered in Guide E2537,or for validation of PAT methods,which is covered in Guide E2898.1.5 For information on science-and risk-based approachesin the pharmaceutical industry,reference should b
10、e made toICH Q8(R2),ICH Q9,and ICH Q10.For guidance on PATsystems in the pharmaceutical industry,reference should bemade to FDA Guidance for IndustryPAT and FDA Guidancefor IndustryProcess Validation,as well as EU Guidelines forGood Manufacturing Practice for Medicinal Products forHuman and Veterina
11、ry Use and EU Guideline on ProcessValidation for Finished Products.1.6 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety,health,and environmental practices and deter
12、-mine the applicability of regulatory limitations prior to use.1.7 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendatio
13、ns issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2E122 Practice for Calculating Sample Size to Estimate,WithSpecified Precision,the Average for a Characteristic of aLot or ProcessE2363 Terminology Relating to Process Analytic
14、al Technol-ogy in the Pharmaceutical IndustryE2476 Guide for Risk Assessment and Risk Control as itImpacts the Design,Development,and Operation of PATProcesses for Pharmaceutical Manufacture1This guide is under the jurisdiction of ASTM Committee E55 on Manufactureof Pharmaceutical and Biopharmaceuti
15、cal Products and is the direct responsibility ofSubcommittee E55.01 on Process Understanding and PAT System Management,Implementation and Practice.Current edition approved June 15,2019.Published July 2019.Originallyapproved in 2011.Last previous edition approved in 2011 as E2629 11.DOI:10.1520/E2629
16、-19.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Princ
