ASTM_E_2500_-_13.pdf

Designation:E250013Standard Guide forSpecification,Design,and Verification of Pharmaceuticaland Biopharmaceutical Manufacturing Systems andEquipment1This standard is issued under the fixed designation E2500;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 is applicable to all elements of pharmaceu-tical and biopharmaceutical manufacturing systems including:facility equipment,process equipment,supporting utilities,associated process monitoring and control systems,and auto-mation systems that have the potential to affect product qualityand patient safety.1.2 For brevity,these are referred to throughout the rest ofthis guide as manufacturing systems.1.3 This guide may also be applied to laboratory,information,and medical device manufacturing systems.1.4 This guide is applicable to both new and existingmanufacturing systems.The approach may be used for theimplementation of changes to existing systems,and theircontinuous improvement during operation.1.5 This guide is applicable throughout the life-cycle of themanufacturing system from concept to retirement.1.6 This standard does not address employee health andsafety,environmental,or other non-GxP regulations.Thisstandard does not purport to address all of the safety concerns,if any,associated with its use.It is the responsibility of the userof this standard to establish appropriate safety and healthpractices and determine the applicability of regulatory limita-tions prior to use.2.Referenced Documents2.1 ASTM Standards:2E2363 Terminology Relating to Process Analytical Technol-ogy in the Pharmaceutical IndustryE2474 Practice for Pharmaceutical Process Design UtilizingProcess Analytical TechnologyE2475 Guide for Process Understanding Related to Pharma-ceutical Manufacture and ControlE2476 Guide for Risk Assessment and Risk Control as itImpacts the Design,Development,and Operation of PATProcesses for Pharmaceutical ManufactureE2537 Guide for Application of Continuous Quality Verifi-cation to Pharmaceutical and Biopharmaceutical Manu-facturingE2629 Guide for Verification of Process Analytical Technol-ogy(PAT)Enabled Control Systems2.2 Other Publications:FDA Guidance for Industry Process Validation:GeneralPrinciples and Practices3ICH Q8 Pharmaceutical Development4ICH Q9 Quality Risk Management4ICH Q10 Pharmaceutical Quality System4ICH Q11 Development and Manufacture of Drug Substances(Chemical Entities and Biotechnological/Biological Enti-ties)4Pharmaceutical cGMPs for the 21st Century A Risk-Based Approach33.Terminology3.1 DefinitionsFor definitions of terms used in this guide,refer to Terminology E2363.3.1.1 acceptance criteriathe criteria that a system orcomponent must satisfy in order to be accepted by a user orother authorized entity.3.1.2 design reviewsplanned and systematic reviews ofspecifications,design,and design development and continuousimprovement changes performed as appropriate throughout the1This guide is under the jurisdiction of ASTM Committee E55 on Manufactureof Pharmaceutical Products and is the direct responsibility of Subcommittee E55.03on General Pharmaceutical Standards.Current edition approved Nov.1,2013.Published November 2013.Originallyapproved in 2007.Last previous edition approved in 2012 as E2500 07(2012).DOI:10.1520/E2500-13.2For 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 Food and Drug Administration(FDA),5600 Fishers Ln.,Rockville,MD 20857,http:/www.fda.gov.4Available 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 life-cycle of the manufacturing system.Design reviews evalu-ate deliverables against standards and requirements,identifyproblems,and propose required corrective actions.3.1.3 manufacturing systemselements of pharmaceuticaland biopharmaceutical manufacturing capability,includingmanufacturing systems,facility equipment,process equipment,supporting utilities,associated process monitoring and controlsystems,and automation systems,that have the potential toaffect product quality and patient safety.3.1.4 subject matter experts(SMEs)individuals with spe-cific expertise and responsibility in a particular area or field(forexample,qualityunit,engineering,automation,development,operations,and so forth).3.1.5 verificationa systematic approach to verify thatmanufacturing systems,acting singly