1、Designation:E265610Standard Practice forReal-time Release Testing of Pharmaceutical Water for theTotal Organic Carbon Attribute1This standard is issued under the fixed designation E2656;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision
2、,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 practice establishes an approach to the real-timerelease testing(RTRT)of pharmaceutical water based on th
3、etotal organic carbon(TOC)attribute using on-line total organiccarbon(OLTOC)instrumentation that is in agreement withcurrent regulatory thinking.1.2 This practice is harmonized with or supports the con-cepts of relevant ASTM International Committee E55 onManufacture of Pharmaceutical Products standa
4、rds,ICH Har-monized Tripartite Guidelines,the US FDAPAT Guidance,andUS FDA Pharmaceutical cGMPs.1.3 This practice does not provide general guidance infor-mation for pharmaceutical procedures that are consideredstandard practice in the pharmaceutical industry.This practiceprovides specific guidance f
5、or non-standardized procedures.1.4 This practice does not address the users various internalprocedures for risk,change,or quality management systems.The overall project effort associated with this practice shall beproportional to the overall risk of failing the pharmaceuticalwaters TOC concentration
6、 specification.1.5 This practice does not purport to establish how tocomply with pharmacopeias.The RTRT methodology selectedmust assure compliance with the users current requiredpharmacopeias.However,compliance with pharmacopeia TOCmethods is not necessarily sufficient to meet current regulatoryexpe
7、ctations for RTRT.1.6 This practice does not purport to substitute for or replacecompendial bioburden testing requirements.It is strictly appli-cable to the TOC attribute of water quality.1.7 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is the
8、responsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E2281 Practice for Process and Measurement CapabilityIndicesE2363 Terminology Relating t
9、o Process Analytical Technol-ogy in the Pharmaceutical IndustryE2500 Guide for Specification,Design,and Verification ofPharmaceutical and Biopharmaceutical ManufacturingSystems and EquipmentE2537 Guide for Application of Continuous Quality Verifi-cation to Pharmaceutical and Biopharmaceutical Manu-f
10、acturingD4839 Test Method for Total Carbon and Organic Carbon inWater by Ultraviolet,or Persulfate Oxidation,or Both,andInfrared DetectionD5173 Test Method for On-Line Monitoring of CarbonCompounds in Water by Chemical Oxidation,by UVLight Oxidation,by Both,or by High Temperature Com-bustion Followe
11、d by Gas Phase NDIR or by ElectrolyticConductivityD5904 Test Method for Total Carbon,Inorganic Carbon,andOrganic Carbon in Water by Ultraviolet,PersulfateOxidation,and Membrane Conductivity DetectionD5997 Test Method for On-Line Monitoring of TotalCarbon,Inorganic Carbon in Water by Ultraviolet,Pers
12、ul-fate Oxidation,and Membrane Conductivity DetectionD6317 Test Method for Low Level Determination of TotalCarbon,Inorganic Carbon and Organic Carbon in Waterby Ultraviolet,Persulfate Oxidation,and Membrane Con-ductivity Detection2.2 Pharmacopoeia Documents:ICH Q2(R1)Validation of Analytical Procedu
13、res:Text andMethodology3ICH Q7 Good Manufacturing Practice Guide for Active1This practice is under the jurisdiction of ASTM Committee E55 on Manufac-ture of Pharmaceutical Products and is the direct responsibility of SubcommitteeE55.03 on General Pharmaceutical Standards.Current edition approved Aug
14、.1,2010.Published October 2010.DOI:10.1520/E2656-10.2For 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 fro
15、m 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 Conshoh
16、ocken,PA 19428-2959.United States1 Pharmaceutical Ingredients3ICH Q8(R1)Pharmaceutical Development3ICH Q9 Quality Risk Management3ICH Q10 Pharmaceutical Quality System3ISO 15839 Water Quality On-line Sensors/AnalyzingEquipment for Water:Specifications and PerformanceTests4JP Chapter Test for Total Organic Carbon5Ph.Eur.Chapter Total Organic Carbon in Waterfor Pharmaceutical Use6US FDA PAT Guidance Guidance for Industry:PAT AFramework for Innovative Pharmaceutical Development,Manufacturing,and Qu
