ASTM E2363-2014 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry《制药业过程技术分析相关标准术语》.pdf

1、Designation: E2363 06aE2363 14Standard 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, th

2、e 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 terminology covers process analytical technology in the pharmaceutical industry. Terms are defined as t

3、hey are usedrelative to the PAT framework in the pharmaceutical industry. Terms that are generally understood and in common usage oradequately defined in other readily available referenceseferences are not included except where particular delineation to processanalytical technology may be more clear

4、ly stated.1.2 This terminology is therefore intended to be selective of terms used generally in process analytical technology as it is appliedin the pharmaceutical industry and published in a number of documents, such as those listed in the succeeding sections. The listingis also intended to define

5、terms that appear prominently within other related ASTM standards and do not appear elsewhere.1.3 The definitions are substantially identical to those published by the U.S. Food and Drug Administration and otherauthoritative bodies, such as ISO, IEC, ITU, and national standards organizations.1.4 Thi

6、s terminology supplements current documents on terminology that concentrate on process analytical technology as it isapplied in the pharmaceutical industry.1.5 An increasing number of product designations and designations for chemical, physical, mechanical, analytical, andstatistical tests and stand

7、ards are coming into common usage in the literature, regulatory environment, and commerce associatedwith process analytical technology in the pharmaceutical industry. Section 2 lists those documents referenced in this terminology.1.6 The values stated in SI units are to be regarded as standard. No o

8、ther units of measurement are included in this standard.2. Referenced Documents2.1 ASTM Standards:2E456 Terminology Relating to Quality and StatisticsE869 Test Method for Performance Evaluation of Fuel Ethanol Manufacturing FacilitiesE1117 Practice for Design of Fuel-Alcohol Manufacturing Facilities

9、E1126 Terminology Relating to Biomass Fuels (Withdrawn 2003)3E1285 Guide for Identification of Bacteriophage Lambda () or Its DNA (Withdrawn 2014)3E1286 Guide for Identification of Herpes Simplex Virus or Its DNA (Withdrawn 2014)3E1287 Practice for Aseptic Sampling of Biological Materials (Withdrawn

10、 2008)3E1298 Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)3E1342 Practice for Preservation by Freezing, Freeze-Drying, and Low Temperature Maintenance of Bacteria, Fungi, Protista,Viruses, Genetic Elements, and Animal and Plant Tissues (

11、Withdrawn 2011)3E1344 Guide for Evaluation of Fuel Ethanol Manufacturing FacilitiesE1493 Guide for Identification of Bacteriophage M13 or Its DNA (Withdrawn 2014)3E1531 Practice for Detection of Mycoplasma Contamination of Cell Cultures by Growth on Agarose Medium (Withdrawn2014)31 This terminology

12、is under the jurisdiction ofASTM Committee E55 on Manufacture of Pharmaceutical Products and is the direct responsibility of Subcommittee E55.91on Terminology.Current edition approved July 15, 2006Dec. 1, 2014. Published July 2006January 2015. Originally approved in 2004. Last previous edition appro

13、ved in 2006 asE2363 06.E2363 06a. DOI: 10.1520/E2363-06A.10.1520/E2363-14.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the

14、ASTM website.3 The last approved version of this historical standard is referenced on www.astm.org.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically

15、 possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C70

16、0, West Conshohocken, PA 19428-2959. United States1E1532 Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of Bisbenzamide DNA-BindingFluorochrome (Withdrawn 2014)3E1533 Practice for Indirect Detection of Mycoplasma in Cell Culture by 4-6-Diamidino-2-2 Phenylindole (DAPI) St

17、aining(Withdrawn 2014)3E1536 Practice for Detection of Mycoplasma Contamination of Bovine Serum by Large Volume Method (Withdrawn 2014)3E1564 Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved BiologicalMaterialsE1565 Guide for Inventory Control and

18、Handling of Biological Material Maintained at Low TemperaturesE1566 Guide for Handling Hazardous Biological Materials in Liquid NitrogenE2500 Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems andEquipmentE2629 Guide for Verification of Pr

19、ocess Analytical Technology (PAT) Enabled Control Systems2.2 U.S. Government Publications:421 CFR 210.3(b) Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs;GeneralDefinitions21 CFR 314.3(b) Applications for FDA Approval to Market a New DrugGeneral Provis

20、ionsDefinitionsFDA/ICH Q7A Guidance Document GMP Guidance for APIs and Its Use During Inspections4FDA/ICH Q9 Guidance for IndustryQuality Risk Management4U.S. FDA PAT Guidance Document Guidance for Industry PATA Framework for Innovative Pharmaceutical Manufacturingand Quality Assurance42.3 ICH Publi

21、cations:5ICH R2 (Q1) Validation of Analytical Procedures: Text and MethodologyICH Q6A Guidance for IndustrySpecifications: Test Procedures and Acceptance Criteria for New Drug Substances and NewDrug Products: Chemical SubstancesICH Q6B Guidance for IndustrySpecifications: Test Procedures and Accepta

22、nce Criteria for Biotechnological/BiologicalProductsICH Q7 Guidance for IndustryGood Manufacturing Practice Guide For Active Pharmaceutical IngredientsICH Q8 (R2) Guidance for IndustryPharmaceutical DevelopmentICH Q9 Guidance for IndustryQuality Risk ManagementICH Q10 Guidance for IndustryPharmaceut

23、ical Quality SystemICH Q11 Guidance for IndustryDevelopment and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)2.4 Other Publication:ISO Publications:6ISO 9000:2005 Quality Management SystemsFundamentals and VocabularyISO EN 14971ISO EN 14971:2012 Medical

24、DevicesApplication of Risk Management for Medical DevicesISO/IEC Guide 51:2014 Safety AspectsGuidelines for Their Inclusion in StandardsISO Guide 73:2009 Risk ManagementVocabulary2.5 Other Publication:EU GMP Glossary3. Terminology3.1 Definitions:acceptance criteria, nnumerical limits, ranges, proces

25、s signatures, or other suitable measures that are necessary for making adecision to accept or reject the result of a process, in-process variable, a product or any other convenient subgroups ofmanufactured units.for acceptance of test results. ICH Q7accuracy, nthe accuracy of an analytical procedure

26、 expresses the closeness of agreement between the value which is acceptedeither as a conventional true value or an accepted reference value and the value found. ICH Q8 (R2)active pharmaceutical ingredient (API) (or drug substance), nany substance or mixture of substances intended to be used inthe ma

27、nufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredientof the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure,mitigation, treatment, or prevention of disease or

28、to affect the structure and function of the body. ICH Q74 Available from U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:/www.access.gpo.gov.5 Available from Food and Drug Administration (FDA), 5600 Fishers Ln., Rockvill

29、e, MD 20857, http:/www.fda.gov.International Conference on Harmonisation ofTechnical Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH Secretariat, c/o IFPMA, 15 ch. Louis-Dunant, P.O. Box 195, 1211 Geneva 20,Switzerland, http:/www.ich.org.6 Available from American National S

30、tandards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.E2363 142analytical procedure, nthe analytical procedure refers to the way of performing the analysis. It should describe in detail thesteps necessary to perform each analytical test. This may include but is

31、 not limited to: the sample, the reference standard andthe reagents preparations, use of the apparatus, generation of the calibration curve, use of the formulae for the calculation, etc.ICH Q8 (R2)analyzer, nan instrument designed to measure and report a property of the process, material, or environ

32、mental condition.API starting material, na raw material, intermediate, or anAPI that is used in the production of anAPI and that is incorporatedas a significant structural fragment into the structure of the API. An API Starting Material can be an article of commerce, amaterial purchased from one or

33、more suppliers under contract or commercial agreement, or produced in-house. API StartingMaterials are normally of defined chemical properties and structure. ICH Q7at-line measurements, nmeasurement where the sample is removed, isolated from, and analyzed in close proximity to theprocess stream.attr

34、ibute, na characteristic or inherent property or feature.batch, na specific quantity of a drug or other material that is intended to have uniform character and quality, within specifiedlimits, and is produced according to a single manufacturing order during the same cycle of manufacture. 21 CFR 210.

35、3(b)batch number, naSee combination of lot number.numbers, letters, and/or symbols that uniquely identifies a batch and fromwhich the production and distribution history can be determined.batch process, na noncontinuous operation in which discrete quantities of material are transformed using individ

36、ual orsequential steps. 21 CFR 210.3(b)bioburden, nthe level and type (for example, objectionable or not) of micro-organisms that can be present in raw materials,APIstarting materials, intermediates or APIs. Bioburden should not be considered contamination unless the levels have beenexceeded or defi

37、ned objectionable organisms have been detected. ICH Q7calibration, nthe demonstration that a particular instrument or device produces results within specified limits by comparisonwith those produced by a reference or traceable standard over an appropriate range of measurements. ICH Q7capability of a

38、 process, nability of a process to realize a product that will fulfil the requirements of that product. The conceptof process capability can also be defined in statistical terms. ISO 9000:2005, ICH Q10change management, na systematic approach to proposing, evaluating, approving, implementing, and re

39、viewing changes. ICHQ10chemical transformation step, nfor chemical entities, a step involved in the synthesis of the chemical structure of the drugsubstance from precursor molecular fragments. Typically it involves C-X or C-C bond formation or breaking. ICH Q11computer system, na group of hardware c

40、omponents and associated software designed and assembled to perform a specificfunction or group of functions.FDA/ICH Q7A Guidance DocumentICH Q7computerized system, na process or operation integrated with a computer system. ICH Q7contaminants, nany adventitiously introduced materials (for example, c

41、hemical, biochemical, or microbial species) not intendedto be part of the manufacturing process of the drug substance or drug product. ICH Q6Bcontamination, nthe undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into oronto a raw material, intermedia

42、te, API (active pharmaceutical ingredient), or dosage form during production, sampling,packaging, or repackaging, storage, or transport. FDA/ICH Q7A Guidance DocumentICH Q7continual improvement, nrecurring activity to increase the ability to fulfil requirements. ISO 9000:2005continuous processa proc

43、ess in which material is added, processed, and removed in an uninterrupted manner.continuous process verification, nan alternative approach to process validation in which manufacturing process performanceis continuously monitored and evaluated. ICH Q8 (R2)contract manufacturer, na manufacturer who p

44、erforms some aspect of manufacturing on behalf of another entity.control number, nSee lot number.control model, nprocedure or mathematical expression (algorithm) that uses the outputs of the process model combined withany other data inputs required to calculate values for the critical control parame

45、ters for the process; it uses input data from theprocess to generate an actionable command or commands that are issued to the control system. E2629E2363 143control strategy, na planned set of controls, derived from current product and process understanding, that assures processperformance and produc

46、t quality. The controls can include parameters and attributes related to drug substance and drug productmaterials and components, facility and equipment operating conditions, in-process controls, finished product specifications, andthe associated methods and frequency of monitoring and control. ICH

47、Q10control system, nsystem that responds to inputs signals from the process, its associated equipment, other programmable systems,or an operator, or combinations thereof, and generates output signals causing the process and its associated equipment to operatein the desired manner. E2629continuous pr

48、ocess,corrective action, na process in which material is added, processed, and removed in an uninterruptedmanner.action to eliminate the cause of a detected non-conformity or other undesirable situation. ISO 9000:2005DISCUSSIONCorrective action is taken to prevent recurrence whereas preventive actio

49、n is taken to prevent occurrence.critical, ndescribes a process step, process condition, test requirement, or other relevant parameter or item that must becontrolled within predetermined criteria to ensure that the API meets its specification. ICH Q7cross-contamination, ncontamination of a material or product with another material or product.FDA/ICH Q7A Guidance DocumentICH Q7current good manufacturing practices (CGMP), ncurrent regulations published by the United States Food and DrugAdministration (FDA) regarding manufact