1、Designation:E289814Standard Guide forRisk-Based Validation of Analytical Methods for PATApplications1This standard is issued under the fixed designation E2898;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.
2、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 provides an overview to the risk-basedvalidation of process analytical methods under a processanalytical technology(PAT)paradi
3、gm for pharmaceuticals andbiopharmaceuticals and as such includes guidance on assessingrisk to product quality from inappropriate method validation.1.2 This guide builds on existing standards on the topic ofvalidation concentrating on applying such standards to analyti-cal methods for on-line analys
4、is.In particular,it addresses thevalidation of at-line,on-line,or in-line PAT measurements andcovers both API and Drug Product(DP)measurements.1.3 The definitions of International Conference on Harmo-nization(ICH)validation parameters(such as specificity,precision,repeatability,etc.)apply;however,th
5、e method ofdemonstrating the validation parameters may vary from thatdescribed in ICH and is discussed.1.4 As consistent with the U.S.Food and Drug Administra-tion(FDA)process validation guidance,this document alsobriefly covers ongoing assurance that the method remains in avalidated state during ro
6、utine use.1.5 Equipment and instrument qualification are out of thescope of this guide but will be referenced as inputs tovalidation of analytical methods for PAT applications.1.6 The validation of multivariate prediction models is outof scope but will be referenced as inputs to validation ofanalyti
7、cal methods for PAT applications.1.7 Microbiological methods are out of scope.1.8 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 determin
8、e the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D3764 Practice for Validation of the Performance of ProcessStream Analyzer SystemsD6122 Practice for Validation of the Performance of Multi-variate Online,At-Line,and Laboratory Infrared Spectro-pho
9、tometer Based Analyzer SystemsE1655 Practices for Infrared Multivariate QuantitativeAnalysisE1790 Practice for Near Infrared Qualitative AnalysisE2056 Practice for Qualifying Spectrometers and Spectro-photometers for Use in Multivariate Analyses,CalibratedUsing Surrogate MixturesE2476 Guide for Risk
10、 Assessment and Risk Control as itImpacts the Design,Development,and Operation of PATProcesses for Pharmaceutical ManufactureE2500 Guide for Specification,Design,and Verification ofPharmaceutical and Biopharmaceutical ManufacturingSystems and EquipmentE2617 Practice for Validation of Empirically Der
11、ived Mul-tivariate CalibrationsE2629 Guide for Verification of Process Analytical Technol-ogy(PAT)Enabled Control SystemsE2656 Practice for Real-time Release Testing of Pharmaceu-tical Water for the Total Organic Carbon Attribute2.2 ICH Standards:3Q2(R1)Guidance on Validation of Analytical Procedure
12、s:Text and MethodologyQ7 Good Manufacturing Practice Guide for Active Pharma-ceutical IngredientsQ9 Quality RiskICH Quality Implementation Working Group Points toConsider(R2)ICH-Endorsed Guide for ICH Q8/Q9/Q10Implementation dated 6 December 20111This guide is under the jurisdiction of ASTM Committe
13、e E55 on Manufactureof Pharmaceutical Products and is the direct responsibility of Subcommittee E55.01on PAT System Management,Implementation and Practice.Current edition approved June 1,2014.Published June 2014.Originallyapproved in 2013.Last previous edition approved in 2013 as E2898 13.DOI:10.152
14、0/E2898-14.2For 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.3Available from International Conference on Harmonisati
15、on of TechnicalRequirements for Registration of Pharmaceuticals for Human Use(ICH),ICHSecretariat,c/o IFPMA,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 2.3 Ot
16、her Standards:ASME BPE2009 BioProcessing Equipment Standard4FDA Guidance for Industry Process Validation:GeneralPrinciples and Practices5ISO 14971 Medical DevicesApplication of Risk Manage-ment to Medical Devices6ISO 15839Water QualityOn-line Sensors/AnalysingEquipment for WaterSpecifications and PerformanceTests6ISO/IEC Guide 51 Safety AspectsGuidelines for TheirInclusion in Standards6USP Acoustic Emission 73.Terminology3.1 Definitions:3.1.1 acceptance criteria,ncriteria that a system or com-po
