ASTM_E_2537_-_08.pdf

Designation:E253708Standard Guide forApplication of Continuous Quality Verification toPharmaceutical and Biopharmaceutical Manufacturing1This standard is issued under the fixed designation E2537;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last 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 Continuous Quality Verification(CQV)as an approach to process validation where manufac-turing process(or supporting utility system)performance iscontinuously monitored,evaluated and adjusted(as necessary).It is a science-based approach to verify that a process is capableand will consistently produce product meeting its predeter-mined critical quality attributes.CQV is similarly described asContinuous Quality Assurance(U.S.FDA)and ContinuousProcess Verification(ICH Q8).1.2 Pharmaceutical and biopharmaceutical product manu-facturing companies are required to provide assurance that theprocesses used to manufacture regulated products result inproducts with the specified critical quality attributes of strengthidentity and purity associated with the product safety,andefficacy.Process validation is a way in which companiesprovide that assurance.1.3 With the knowledge obtained during the product life-cycle,a framework for continuous quality improvement will beestablished where the following may be possible:(1)riskmitigated,(2)process variability reduced,(3)process capabil-ity enhanced,(4)process design space defined or enhanced,and ultimately(5)product quality improved.This can enable anumber of benefits that address both compliance and opera-tional goals(for example,real time release,continuous processimprovement).1.4 The principles in this guide may be applied to drugproduct or active pharmaceutical ingredient/drug substancepharmaceutical and biopharmaceutical batch or continuousmanufacturing processes or supporting utility systems(forexample,TOC for Purified Water and Water for Injectionsystems,and so forth).1.5 The principles in this guide may be applied during thedevelopment and manufacturing of a new process or product orfor the improvement and/or redesign of an existing process.1.6 Continuous quality verification may be applied to manu-facturing processes that use monitoring systems that providefrequent and objective measurement of process data.Theseprocesses may or may not employ in-,on-,or at-line analyzers/controllers that monitor,measure,analyze,and control theprocess performance.The associated processes may or may nothave a design space.1.7 This guide may be used independently or in conjunctionwith other proposed E55 standards to be published by ASTMInternational.2.Referenced Documents2.1 ASTM Standards:2E2363 Terminology Relating to Process Analytical Technol-ogy in the Pharmaceutical Industry2.2 Other Publications:ICH Q8 Pharmaceutical Development(Step 4 version),10November 20053ICH Q9 Quality Risk Management(Step 4 version),9November 20053Pharmaceutical cGMPs for the 21st Century A Risk-Based Approach4Guidance for Industry,PAT A Framework for InnovativePharmaceutical Development,Manufacturing and QualityAssurance41This guide is under the jurisdiction of ASTM Committee E55 on Manufactureof Pharmaceuticals Products and is the direct responsibility of SubcommitteeE55.03 on General Pharmaceutical Standards.Current edition approved Jan.1,2008.Published February 2008.DOI:10.1520/E2537-08.2For 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 Harmonisation 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.4Available from Food and Drug Administration(FDA),5600 Fishers Ln.,Rockville,MD 20857,http:/www.fda.gov.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.Terminology3.1 For definitions of terms used in this guide,refer toTerminology E2363.4.Significance and Use4.1 Application of the approach described within this stan-dard guide applies science-based concepts and principlesintroduced in the FDAinitiative Pharmaceutical cGMPs for the21st Century.4.2 This guide supports,and is consistent with,elementsfrom ICH Q8 and ICH Q9.4.3 According to FDA Guidance for Industry,PAT,“Withreal time quality assurance,the desired quality attributes areensured through continuous assessment during manufacture.Data from production batches can serve to validate the processand reflect the total system design concept,essentially support-ing validation with each manufacturing batch.”In other words,the accumulated