CTD格式要求(英文版)(共8页)

1、精选优质文档-倾情为你奉上2. 3. P DRUG PRODUCT (NAME, DOSAGE FORM)2.3.P.1 Description and Composition of the Drug Product（1）A description of the dosage of drug product and its composition should be provided with a table to present the action of each composition and the specification. Overages should be explained

2、 and the dissolvent which is used but removed in the end should be in the table.CompositionamountOveragesactionspecificationthe dissolvent which is used but removed in the end(2) If there is special dissolvent, please fill the table as above.(3) Description of container and material of package.2.3.P

3、.2 Pharmaceutical DevelopmentSummarize the purpose of the development, including dosage, strength and reason of the selection.2.3.P.2.1 Components of the Drug Product2.3.P.2.1.1 Drug substanceSummarize the compatibility of the drug substance with excipients. Refer to 3.2.P.2.1.1 (Page: ) for the det

4、ails.Additionally, summarize key physicochemical characteristics (e.g., solubility, particle size distribution, or crystal form) of the drug substance that can influence the performance of the drug product and also the control of all this characteristics. 2.3.P.2.1.2 ExcipientsGenerally introduce th

5、e types and the tests and/ or reference of amount selection. Refer to 3.2.P.2.1.2 (Page: ) for the details.2.3.P.2.2 Pharmaceutical Development2.3.P.2.2.1 Formulation DevelopmentRefer to 3.2.P.2.2.1(Page: ) for the process of formulation development and supporting information.A tabulated summary of

6、the variation and reasons of formulation of different development steps, as well as supporting validation tests should be provided. For example:Formulation of laboratory scale testsFormulation of pilot scale testsFormulation of large scale testsMain variation and reasonsSupporting informationExcessi

7、ve feeding: Supporting information about excessive feeding.2.3.P.2.2.2 Properties of drug productsSummary relevant to the performance of the drug product, such as pH, ionic strength, dissolution, redispersion, reconstitution, particle size distribution, polymorphism, rheological properties, should b

8、e addressed. The quality comparative tests results between the products and innovator in the formulation development should be provided. For example:(1) Dissolution of oral solid preparations: batch number, batch number and manufacture of the innovator; condition of dissolution, sampling points; com

9、parative tests results.(2) Related substance: batch number, batch number and manufacture of the innovator; methods of tests and calculation; comparative tests results.2.3.P.2.3 Manufacturing Process DevelopmentRefer to 3.2.P.2.3(Page: ) for the details of the selection and optimization of manufactur

10、ing process.A tabulated summary of the variation and related supporting research information from lab scale tests to large scale tests, including batch size, devices, parameters, etc. should be provided.Example:Summary of the variation of manufacturing processmanufacturing process of laboratory scal

11、e testsmanufacturing process of pilot scale testsmanufacturing process of large scale testsMain variation Supporting informationSummarized the sample condition of representative batches (including but not limited to clinical research batch, pilot scale batch, on-site verification batch, process vali

12、dation batch). Batch number, manufacture date and address, batch scale, purpose (eg. Stability tests, BE tests, etc.), analysis results(eg. Related substance, dissolution and other quality indications)Example:Summary of batch analysisBatch No.Manufacture dateManufacture addressScalerecoverypurposequ

13、alityAssayImpurityOther indications2.3.P.2.4 Packing material/ ContainerItemContainerAccessories*Type* of Packing materialManufacturer of Packing materialRegistration No. of Packing materialValid date of licenseNumber of approved specification *including material and strength *including the accessor

14、ies which contact the drug directly, such as combined with polypropylene plastic containers infusion and plastic containers with polypropylene interface infusionRefer to 3.2.P.2.4 (Page: ) for the details.2.3.P.2.5 Compatibility Summarize the compatibility of the drug product with diluent(s) or dosa

15、ge devices. Refer to 3.2.P. 2.5 (Page: ) for the details.2.3.P.3 Manufacture2.3.P.3.1 ManufacturesThe name (full name), address, telephone number and fax of each manufacturer and each proposed production site or facility involved in manufacturing and testing should be provided.2.3.P.3.2 batch formul

16、aA description of the composition of drug product in scale for production should be provided with a table to present the action of each composition and the specification. Overages should be explained and the dissolvent which is used but removed in the end should be in the table. CompositionamountOve

17、ragesactionspecificationthe dissolvent which is used but removed in the end2.3.P.3.3 Manufacturing Process and Process Controls(1) flow diagram of process: refer to 3.2.P.3.3 (Page: )(2) description of manufacturing process: Main processes, parameters and scales should be identified by a brief descr

18、iption of each manufacturing process (including steps). Refer to 3.2.P.3.3 (Page: )(3) Main equipments: Refer to 3.2.P.3.3 (Page: )(4) draft scale of large production: units of drug product/batch (oral preparation, etc. ) or volume of solution before filled/batch (solution, injection, etc).2.3.P.3.4

19、 Controls of Critical Steps and IntermediatesList all the critical steps and the parameter control ranges of manufacture process Refer to 3.2.P.3.4 for the details of identification of critical steps and the parameter control ranges of manufacture process.Refer to 3.2.P.3.4 for the details of qualit

20、y control of intermediates2.3.P.3.5 Process Validation and Evaluationaseptic and specified processing preparation: protocol of process validation (No. version number: ) and validation report (No. version number: ). Refer to 3.2.P.3.5(Page: )other preparation: protocol of process validation (No. vers

21、ion number: ) and validation report (No. version number: ). Refer to 3.2.P.3.5(Page: ); Otherwise, protocol of process validation (No. version number: ) and report of batch production (No. version number: ). Refer to 3.2.P.3.5 for the details of draft and validation undertaking (Page: )2.3.P.4 Contr

22、ol of Drug substance and ExcipientsCompositionManufacturerApproval numberSpecification Using and removal of the dissolvent during process2.3.P.5 Control of Drug Product2.3.P.5.1 SpecificationA tabulated summary of specification should be provided as below. If there are release and shelf life specifi

23、cation, please explain each one in the table. Refer to 3.2.P.5.1(Page: ) for the details of specification.ItemMethodRelease specificationShelf life specificationDescriptionidentificationDegradation substancedissolutionContents uniformity/weight variation Resident solventwaterParticle size distributi

24、onsterilitybacterial endotoxinothersassay2.3.P.5.2 analysis methodsList chromatographic condition of each method: degradation substance, resident solvent, assay, etc.List the dissolution condition and quantitative method, etc.Refer to 3.2.P.5.2 for the details of analysis methods.2.3.P.5.3 Validatio

25、n of Analytical ProceduresThe validation results should be tabulated as following:Example:Method validation of related substanceitemresultspecificityDisturbance of excipients; separation of known impurities; separation tests of the substance hard to separate; stress tests; Linearity & rangeRelat

26、ed to known impuritiesDetection limit and quantitation limitaccuracyRelated to known impuritiesPrecisionRepeatability and intermediate precisionStability of solutionDurabilitySystem durability, extraction stabilityRefer to 3.2.P.5.3 (Page: )2.3.P.5.4 Certificate of analysis Refer to 3.2.P.5.4(Page:

27、) for the COAs of 3 batches(batch number: )2.3.P.5.5 Impurity analysisA tabulated summary of impurities should be supplied.For example:Analysis of impuritiesImpuritystructureResourceControl limitIn specification(Yes/No)Refer to 3.2.P.5.5 for the details(Page: )2.3.P.5.6 Justification of Specificatio

28、nRefer to 3.2.P.5.6 for the details(Page: )2.3.P.6 Reference StandardsPharmacopoeia Reference: resource, batch numberWorking standard: summarize the methods and results of standardization of assay and purification2.3.P.7 Stability2.3.P.7.1 Summary of stability(1) sample:Batch numberStrengthResource

29、and batch number of APIManufacture dateManufacture addressBatch sizeInner packing material (2) testsStability resultsItemsConditionsCompleted period (planed period)Stress testsHigh temperatureHigh humidityLight stressOther testsAccelerated stability testsIntermediate condition testsLong term stabili

30、ty testsOther testsIn-use stability resultsItemStorage conditionTest periodTest itemAnalysis method and validationresultcompatible stabilityOpen multi-dose products stabilitycompatibility tests of drug products with deviceOther tests2.3.P.7.2 Post-marketing stability commitment and protocolRefer to 3.2.P.7.2 for the details (Page: