1、Designation:E236314Standard Terminology Relating toProcess Analytical Technology in the PharmaceuticalIndustry1This standard is issued under the fixed designation E2363;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 terminology covers process analytical technologyin the pharmaceutical industry.Terms are defined as they areused relative
3、to the PAT framework in the pharmaceuticalindustry.Terms that are generally understood and in commonusage or adequately defined in other readily available eferencesare not included except where particular delineation to processanalytical technology may be more clearly stated.1.2 This terminology is
4、therefore intended to be selective ofterms used generally in process analytical technology as it isapplied in the pharmaceutical industry and published in anumber of documents,such as those listed in the succeedingsections.The listing is also intended to define terms that appearprominently within ot
5、her related ASTM standards and do notappear elsewhere.1.3 The definitions are substantially identical to those pub-lished by the U.S.Food and Drug Administration and otherauthoritative bodies,such as ISO,IEC,ITU,and nationalstandards organizations.1.4 This terminology supplements current documents o
6、nterminology that concentrate on process analytical technologyas it is applied in the pharmaceutical industry.1.5 An increasing number of product designations anddesignations for chemical,physical,mechanical,analytical,and statistical tests and standards are coming into commonusage in the literature
7、,regulatory environment,and commerceassociated with process analytical technology in the pharma-ceutical industry.Section 2 lists those documents referenced inthis terminology.1.6 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.2
8、.Referenced Documents2.1 ASTM Standards:2E456 Terminology Relating to Quality and StatisticsE869 Test Method for Performance Evaluation of FuelEthanol Manufacturing FacilitiesE1117 Practice for Design of Fuel-Alcohol ManufacturingFacilitiesE1126 Terminology Relating to Biomass Fuels(Withdrawn2003)3E
9、1285 Guide for Identification of Bacteriophage Lambda()or Its DNA(Withdrawn 2014)3E1286 Guide for Identification of Herpes Simplex Virus orIts DNA(Withdrawn 2014)3E1287 Practice forAseptic Sampling of Biological Materials(Withdrawn 2008)3E1298 Guide for Determination of Purity,Impurities,andContamin
10、ants in Biological Drug Products(Withdrawn2014)3E1342 Practice for Preservation by Freezing,Freeze-Drying,and Low Temperature Maintenance of Bacteria,Fungi,Protista,Viruses,Genetic Elements,and Animal and PlantTissues(Withdrawn 2011)3E1344 Guide for Evaluation of Fuel Ethanol ManufacturingFacilities
11、E1493 Guide for Identification of Bacteriophage M13 or ItsDNA(Withdrawn 2014)3E1531 Practice for Detection of Mycoplasma Contaminationof Cell Cultures by Growth on Agarose Medium(With-drawn 2014)3E1532 Practice for Detection of Mycoplasma Contaminationof Cell Cultures by Use of Bisbenzamide DNA-Bind
12、ingFluorochrome(Withdrawn 2014)3E1533 Practice for Indirect Detection of Mycoplasma in CellCulture by 4-6-Diamidino-2-2 Phenylindole(DAPI)Staining(Withdrawn 2014)31This terminology is under the jurisdiction of ASTM Committee E55 onManufacture of Pharmaceutical and Biopharmaceutical Products and is t
13、he directresponsibility of Subcommittee E55.91 on Terminology.Current edition approved Dec.1,2014.Published January 2015.Originallyapproved in 2004.Last previous edition approved in 2006 as E2363 06a.DOI:10.1520/E2363-14.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact AS
14、TM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C70
15、0,West Conshohocken,PA 19428-2959.United States1 E1536 Practice for Detection of Mycoplasma Contaminationof Bovine Serum by Large Volume Method(Withdrawn2014)3E1564 Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopre-served Biological MaterialsE1565 Guide f
16、or Inventory Control and Handling of Bio-logical Material Maintained at Low TemperaturesE1566 Guide for Handling Hazardous Biological Materialsin Liquid NitrogenE2500 Guide for Specification,Design,and Verification ofPharmaceutical and Biopharmaceutical ManufacturingSystems and EquipmentE2629 Guide for Verification of Process Analytical Technol-ogy(PAT)Enabled Control Systems2.2 U.S.Government Publications:421 CFR 210.3(b)Current Good Manufacturing Practice inManufacturing,Processing,Packing,or
