1、Designation:E3106181Standard Guide forScience-Based and Risk-Based Cleaning ProcessDevelopment and Validation1This standard is issued under the fixed designation E3106;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.1NOTECorrections were made editorially to 3.1.13 in October 2018.1.Scope1.1 This guide applies the life-cycle approach to cleaningprocessva
3、lidation,whichincludesthedevelopment,qualification,and verification of cleaning processes.It isapplicable to pharmaceuticals(including active pharmaceuticalingredients(APIs);dosage forms;and over-the-counter,veterinary,biologics,and clinical supplies)and is also appli-cable to other health,cosmetics
4、,and consumer products.1.2 This guide is focused only on the cleaning of equipmentproduct contact surfaces and does not cover disinfection ornon-product contact surfaces(which are covered under otherexisting guides:Ref(1),2USP,Guide E2614,and ISO14698).1.3 The values stated in SI units are to be reg
5、arded asstandard.No other units of measurement are included in thisstandard.1.4 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
6、and deter-mine the applicability of regulatory limitations prior to use.1.5 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
7、-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:3E1325 Terminology Relating to Design of ExperimentsE2476 Guide for Risk Assessment and Risk Control as itImpacts the Design,Development,and Operation of PATProcesses
8、for Pharmaceutical ManufactureE2614 Guide for Evaluation of Cleanroom Disinfectants2.2 ICH Standards:4Q8 Pharmaceutical DevelopmentQ9 Quality Risk ManagementQ10 Pharmaceutical Quality SystemQ11 Development and Manufacture of Drug Substances2.3 ISO Standards:5ISO 9000 Quality Management SystemsFundam
9、entalsand VocabularyISO14698 GuideforEvaluationofCleanroomDisinfectants,Parts 13.2.4 Federal Standards:621 CFR 211.67 Equipment Cleaning and Maintenance2.5 USP Standards:7USP Disinfectants and Antiseptics1This guide is under the jurisdiction of ASTM Committee E55 on Manufactureof Pharmaceutical and
10、Biopharmaceutical Products and is the direct responsibility ofSubcommittee E55.03 on General Pharmaceutical Standards.Current edition approved Sept.1,2018.Published September 2018.Originallyapproved in 2017.Last previous edition approved in 2017 as E3106 17.DOI:10.1520/E3106-18E01.2The boldface numb
11、ers in parentheses refer to a list of references at the end ofthis standard.3For 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 AST
12、M website.4Available from International Conference on Harmonisation of TechnicalRequirements for Registration of Pharmaceuticals for Human Use(ICH),ICHSecretariat,9,chemin des Mines,P.O.Box 195,1211 Geneva 20,Switzerland,http:/www.ich.org.5Available from American National Standards Institute(ANSI),2
13、5 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.6Available from U.S.Government Printing Office,Superintendent ofDocuments,732 N.Capitol St.,NW,Washington,DC 20401-0001,http:/www.access.gpo.gov.7Available from U.S.Pharmacopeial Convention(USP),12601 TwinbrookPkwy.,Rockville,MD 20852-1790,
14、http:/www.usp.org.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 Principles for theDevelop
15、ment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 3.Terminology3.1 Definitions:3.1.1 acceptable daily exposure,ADE,nrepresents a dosethat is unlikely to cause an adverse effect if an individual isexposed,by a
16、ny route,at or below this dose every day for alifetime.3.1.1.1 DiscussionThis is the term used in the ISPERisk-MaPP Guide(1)and is equivalent to the acceptable dailyintake(ADI)but is associated with any route of administration.3.1.2 acceptable daily intake,ADI,nmeasure of theamount of a specific substance(originally applied for a foodadditive,later also for a residue of a veterinary drug orpesticide)in food or drinking water that can be ingested(orally)on a daily basis over a lifetime without an
