1、Designation:E262911Standard 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.1.4 The principles described in this guide are applicable toa PAT-enabled control system and also to its componentsubsystems.This guide does not cover the requirements forcontinuous quality verification of the overall process,whichare covered in Guide E2537.1.5 Fo
9、r information on science-and risk-based approachesin the pharmaceutical industry,reference should be 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.1
10、.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 and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Docume
11、nts2.1 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 Analytical Technol-ogy in the Pharmaceutical IndustryE2476 Guide for Risk Assessment and Risk Control as itImp
12、acts the Design,Development,and Operation of PATProcesses for Pharmaceutical ManufactureE2500 Guide for Specification,Design,and Verification ofPharmaceutical and Biopharmaceutical ManufacturingSystems and EquipmentE2537 Guide for Application of Continuous Quality Verifi-cation to Pharmaceutical and
13、 Biopharmaceutical Manu-facturing2.2 Other Standards:ICH Q2(R1)Validation of Analytical Procedures:Text andMethodology3ICH Q8(R2)Pharmaceutical Development3ICH Q9 Risk Management3ICH Q10 Pharmaceutical Quality System31This guide is under the jurisdiction of ASTM Committee E55 on Manufactureof Pharma
14、ceutical Products and is the direct responsibility of Subcommittee E55.01on PAT System Management,Implementation and Practice.Current edition approved April 15,2011.Published May 2011.DOI:10.1520/E2629-11.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Serv
15、ice at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from International Conference on Harmonisation of TechnicalRequirements for Registration of Pharmaceuticals for Human Use(ICH),ICHSecretariat,c/o IFPM
16、A,15 ch.Louis-Dunant,P.O.Box 195,1211 Geneva 20,Switzerland,http:/www.ich.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 FDA Guidance for IndustryPAT A Framework for Inno-vative Pharmaceutical Development,Manufacturing andQuality Assurance4FDA Guidance for IndustryProcess Validation GeneralPrinciples and Practices43.Terminology3.1 Definitions:3.1.1 See also Terminology E2363 for other PAT terms.3.1.2 attribute,ncharacteristic or