ASTM E2363-2006a Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry《关于制药业过程技术分析的标准术语》.pdf

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1、Designation: E 2363 06aStandard Terminology Relating toProcess Analytical Technology in the PharmaceuticalIndustry1This standard is issued under the fixed designation E 2363; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year

2、 of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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 ar

3、eused relative to the PAT framework in the pharmaceuticalindustry. Terms that are generally understood and in commonusage or adequately defined in other readily available refer-ences are not included except where particular delineation toprocess analytical technology may be more clearly stated.1.2 T

4、his terminology is 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 appear

5、prominently within other 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 suppl

6、ements current documents onterminology 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

7、commonusage in the literature, regulatory environment, and commerceassociated with process analytical technology in the pharma-ceutical industry. Section 2 lists those documents referenced inthis terminology.2. Referenced Documents2.1 ASTM Standards:2E 456 Terminology Relating to Quality and Statist

8、ics2.2 U.S. Government Publications:21 CFR 210.3(b) Current Good Manufacturing Practice inManufacturing, Processing, Packing, or Holding of Drugs;GeneralDefinitions321 CFR 314.3(b) Applications for FDAApproval to Marketa New DrugGeneral ProvisionsDefinitions3FDA/ICH Q7A Guidance Document, GMP Guidan

9、ce forAPIs and Its Use During Inspections4FDA/ICH Q9 Guidance for IndustryQuality Risk Man-agement4U.S. FDA PAT Guidance Document, Guidance for IndustryPATA Framework for Innovative PharmaceuticalManufacturing and Quality Assurance42.3 Other Publication:ISO EN 14971 Medical DevicesApplication of Ris

10、kManagement for Medical Devices53. Terminology3.1 Definitions:acceptance criteria, nnumerical limits, ranges, processsignatures, or other suitable measures that are necessary formaking a decision to accept or reject the result of a process,in-process variable, a product or any other convenientsubgro

11、ups of manufactured units.analyzer, nan instrument designed to measure and report aproperty of the process, material, or environmental condi-tion.at-line measurements, nmeasurement where the sample isremoved, isolated from, and analyzed in close proximity tothe process stream.attribute, na character

12、istic or inherent property or feature.batch, na specific quantity of a drug or other material that isintended to have uniform character and quality, withinspecified limits, and is produced according to a singlemanufacturing order during the same cycle of manufacture.21 CFR 210.3(b)2batch number, na

13、combination of numbers, letters, and/or1This terminology is under the jurisdiction of ASTM Committee E55 onPharmaceutical Application of Process Analytical Technology and is the directresponsibility of Subcommittee E55.91 on Terminology.Current edition approved July 15, 2006. Published July 2006. Or

14、iginallyapproved in 2004. Last previous edition approved in 2006 as E 2363 06.2For 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 on

15、the ASTM website.3Available from U.S. Government Printing Office Superintendent of Documents,732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.4Available from Food and Drug Administration, 5600 Fishers Ln., Rockville,MD 20857.5Available from American National Standards Institute (ANSI), 2

16、5 W. 43rd St.,4th Floor, New York, NY 10036.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.symbols that uniquely identifies a batch and from which theproduction and distribution history can be determined.batch process, na noncontinu

17、ous operation in which dis-crete quantities of material are transformed using individualor sequential steps. 21 CFR 210.3(b)2computer system, na group of hardware components andassociated software designed and assembled to perform aspecific function or group of functions.FDA/ICH Q7A Guidancecontamin

18、ation, nthe undesired introduction of impurities ofa chemical or microbiological nature, or of foreign matter,into or onto a raw material, intermediate, API (activepharmaceutical ingredient), or dosage form during produc-tion, sampling, packaging, or repackaging, storage, or trans-port. FDA/ICH Q7A

19、Guidancecontract manufacturer, na manufacturer who performssome aspect of manufacturing on behalf of another entity.continuous process, na process in which material is added,processed, and removed in an uninterrupted manner.cross-contamination, ncontamination of a material or prod-uct with another m

20、aterial or product.FDA/ICH Q7A GuidanceDesign of Experiments (DoE), nthe arrangement in whichan experimental program is to be conducted, and theselection of the levels (versions) of one or more factors orfactor combinations to be included in the experiment.Terminology E 456deviation, ndeparture from

21、 an approved instruction or es-tablished standard. FDA/ICH Q7A Guidancedrug product, na drug product is a finished dosage form (forexample, tablets, capsule, or solution) that contains a drugsubstance, generally, but not necessarily, in association withone or more other ingredients. 21 CFR 314.3(b)i

22、mpurity, nany component present in a raw material, inter-mediate, API, or dosage form that is not the desired entity.impurity profile, na description of the identified and uni-dentified impurities present in a raw material, intermediate,API, or dosage form.in-line measurements, nmeasurement where th

23、e sample isnot removed from the process stream, and can be invasive ornon-invasive.in-process material, nany material(s) fabricated, com-pounded, blended, or synthesized using a chemical, physical,or biological process that is produced for and being used inthe preparation of an intermediate, drug su

24、bstance, or drugproduct.in-process tests, nmeasurements performed during manu-facturing and pertaining to the process or products within theprocess.intermediate, nmaterial produced during manufacture thatundergoes further change or purification. Intermediates mayor may not be isolated.lot number, ns

25、ee batch number.manufacture, nall operations of receipt of materials, pro-duction, packaging, repackaging, labeling, relabeling, qual-ity control, release, storage, and distribution of APIs or drugproducts and related controls. FDA/ICH Q7A Guidancemanufacturing process, na set of activities or opera

26、tionsperformed to deliver a desired output.material, na general term used to denote raw materials(starting materials, reagents, solvents), process aids, inter-mediates, APIs, and packaging and labeling materials.FDA/ICH Q7A Guidancematerial specification, na set of criteria to which a materialmust c

27、onform to be considered acceptable for its intendeduse.mother liquor, nthe residual liquid that remains after thecrystallization or isolation processes.DISCUSSIONA mother liquor may contain unreacted materials,intermediates, API, and/or impurities. It can be used for furtherprocessing.FDA/ICH Q7A Gu

28、idanceoff-line measurements, nmeasurement where the sample isremoved, isolated from, and analyzed in an area remote fromthe manufacturing process.on-line measurements, nmeasurement where the sample isdiverted from the manufacturing process, and may bereturned to the process stream.packaging material

29、, nany material intended to contain andprotect a raw material, intermediate, API, or product duringstorage and transport.parameter, na measurable or quantifiable characteristic of asystem or process.parametric release, na system of release that gives assur-ance that the product is of the intended qu

30、ality based on theinformation collected during the manufacturing process.procedure, na documented description of the operations tobe performed, the precautions to be taken, and the measuresto be applied directly or indirectly related to the manufactureof an intermediate, API, or drug product.FDA/ICH

31、 Q7A Guidanceprocess aids, nmaterials, excluding solvents, used as an aidin the manufacture of an intermediate or API that do notthemselves participate in a chemical or biological reaction(for example, filter aid, activated carbon).FDA/ICH Q7A Guidanceprocess analytical technology (PAT), nsystem for

32、 design-ing, analyzing, and controlling manufacturing throughtimely measurements of critical quality and performanceattributes of raw and in-process materials and processes withthe goal of ensuring final product quality.U.S. FDA PAT Guidanceprocess control, nchecks performed during manufacturingto m

33、easure critical attributes and, if appropriate, adjust theprocess to deliver the desired output(s).FDA/ICH Q7A Guidanceprocess parameter, nan attribute of the manufacturingsystem.qualification, naction of proving and documenting thatequipment or ancillary systems are properly installed, workcorrectl

34、y, and actually lead to the expected results.E 2363 06a2FDA/ICH Q7A Guidancequality assurance (QA), nthe sum total of the organizedarrangements made with the object of ensuring that all APIsor drug products are of the quality required for their intendeduse and that quality systems are maintained.FDA

35、/ICH Q7A Guidancequality attribute, nan attribute that affects product quality.quality unit(s), nan organizational unit independent ofproduction that fulfills both quality assurance and qualitycontrol responsibilities.DISCUSSIONThis can be in the form of separate QA and QC units ora single individua

36、l or group, depending upon the size and structure ofthe organization.FDA/ICH Q7A Guidancequarantine, nthe status of materials isolated physically orby other effective means pending a decision on their subse-quent approval or rejection. FDA/ICH Q7A Guidanceraw material, na general term used to denote

37、 startingmaterials, reagents, and solvents intended for use in theproduction of intermediates, APIs, or products.reference standard, primary, na substance that has beenshown by an extensive set of analytical tests to be authenticmaterial that should be of high purity.DISCUSSIONThis standard can be:

38、(1) obtained from an officiallyrecognized source, (2) prepared by independent synthesis, (3) obtainedfrom existing production material of high purity, or (4) prepared byfurther purification of existing production material.FDA/ICH Q7A Guidancereference standard, secondary, na substance of established

39、quality and purity, as shown by comparison to a primaryreference standard, used as a reference standard for routinelaboratory analysis. FDA/ICH Q7A Guidanceretest date, nthe date when a material should be re-examined to ensure that it is still suitable for use.FDA/ICH Q7A Guidancerisk, ncombination

40、of the probability of occurrence of harmand the severity of that harm. ISO EN 14971risk analysis, nsystematic use of available information toidentify hazards and to estimate risk. ISO EN 14971risk assessment, noverall process comprising a risk analysisand a risk evaluation. ISO EN 14971risk evaluati

41、on, nthe comparison of the estimated risk togiven risk criteria using a quantitative or qualitative scale todetermine the significance of the risk.FDA/ICH Q9 Guidancesafety, nfreedom from unacceptable risk. ISO EN 14971sample, na portion, piece, or segment that is representativeof a whole.solvent, n

42、an inorganic or organic liquid used as a vehicle forthe preparation of solutions or suspensions in the manufac-ture of an intermediate, API, or drug product.FDA/ICH Q7A Guidancestarting material, na raw material, intermediate, or an APIthat is used in the production of an API or product and thatis i

43、ncorporated as a significant structural fragment into thestructure of the API or dosage form.DISCUSSIONA starting material can be an article of commerce, amaterial purchased from one or more suppliers under contract orcommercial agreement, or produced in-house. Starting materials arenormally of defi

44、ned chemical properties and structure.validation protocol, na written plan stating how validationwill be conducted and defining acceptance criteria.DISCUSSIONFor example, the protocol for a manufacturing processidentifies processing equipment, critical process parameters and/oroperating ranges, prod

45、uct characteristics, sampling, test data to becollected, number of validation runs, and acceptable test results.FDA/ICH Q7A Guidanceyield, expected, nthe quantity of material or the percentageof theoretical yield anticipated at any appropriate phase ofproduction based on previous laboratory, pilot s

46、cale, ormanufacturing data. FDA/ICH Q7A Guidanceyield, theoretical, nthe quantity that would be produced atany appropriate phase of production based upon the quantityof material to be used, in the absence of any loss or error inactual production. FDA/ICH Q7A GuidanceASTM International takes no posit

47、ion respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibilit

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49、 International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obt