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3.2.S Drug Substance

原料藥部分

3.2.S.1 General Information

基本信息

- What are the nomenclature, molecular structure, molecular formula, and molecular weight?

-化合物的命名、分子結(jié)構(gòu)、分子式和分子量？

- What are the physicochemical properties including physical description, pKa,

polymorphism, aqueous solubility (as function of pH), hygroscopicity, melting points, and partition coefficient?

-化合物的物理化學性質(zhì)，包括物理描述、pKa、多晶態(tài)性、水溶性(作為pH值的函數(shù))、吸濕性、熔點和分配系數(shù)？

3.2.S.2 Manufacture生產(chǎn)

- Who manufactures the drug substance?

生產(chǎn)場地在哪？

- How do the manufacturing processes and controls ensure consistent production of drug substance?

生產(chǎn)工藝和控制如何確保原料藥的一致性？

3.2.S.3 Characterization特性

- How was the drug substance structure elucidated and characterized?

原料藥結(jié)構(gòu)是如何闡明和鑒定？

- How were potential impurities identified and characterized?

潛在雜質(zhì)是如何識別和鑒定？

3.2.S.4 Control of Drug Substance原料藥質(zhì)量控制

- What is the drug substance specification? Does it include all the critical drug substance attributes that affect the manufacturing and quality of the drug product?

-原料藥的質(zhì)量標準是什么？它包括所有的關(guān)鍵屬性嗎？這些屬性影響制劑的生產(chǎn)和屬性。

- For each test in the specification, is the analytical method(s) suitable for its intended use and, if necessary, validated? What is the justification for the acceptance criterion?

-對于質(zhì)量標準中的每一項測試，分析方法是否適用于其使用，如有必要，進行驗證？質(zhì)量標準的理由是什么？

3.2.S.5 Reference Standards對照品

How were the primary reference standards certified?

初級對比照品是如何標化的？

3.2.S.6 Container Closure System包裝系統(tǒng)

What container closure system is used for packaging and storage of the drug substance?

原料藥包裝系統(tǒng)是什么？

3.2.S.7 Stability穩(wěn)定性

- What drug substance stability studies support the retest or expiration date and storage conditions for the drug substance?

支持原料藥復測期或有效期、儲存條件的穩(wěn)定性研究是什么？

- Any statement/commitment?

有穩(wěn)定性聲明或承諾嗎？

3.2.P Drug Product制劑

3.2.P.1 Description and Composition描述和組分

- What are the components

組分是什么？

- Does any excipient exceed the limit for this route of administration?

輔料的含量是否超過該使用途徑的用量？

- Do the differences between this formulation and the reference listed drug present potential concerns with respect to therapeutic equivalence?

處方和參比制劑的處方是否有差異？

3.2.P.2 Pharmaceutical Development制劑開發(fā)

3.2.P.2.1 Components of the Product制劑成分

3.2.P.2.1.1 Drug Substance原料藥

Which properties or physical chemical characteristics of the drug substance affect drug product development, manufacture, or performance?

原料藥的哪些性質(zhì)或物理化學特征影響制劑開發(fā)、生產(chǎn)或性能？

3.2.P.2.1.2 Excipients輔料

What evidence supports compatibility between the excipients and the drug substance?

有什么證據(jù)支持輔料和原料藥的相容性？

3.2.P.2.2 Drug Product制劑

- What attributes should the drug product possess?

制劑含有的屬性是什么？

- How was the drug product designed to have these attributes?

制劑如何開發(fā)為含有這些屬性？

- Were alternative formulations or mechanisms investigated?

是否有替代處方或機制研究？

- How were the excipients and their grades selected?

輔料和級別是如何選擇的？

- How was the final formulation optimized?

最終處方是如何優(yōu)化的？

3.2.P.2.3 Manufacturing Process Development生產(chǎn)工藝開發(fā)

- Why was the manufacturing process described in 3.2.P.3 selected for this drug product?

為什么選擇在3.2.P.3中描述的生產(chǎn)工藝生產(chǎn)該制劑？

- How are the manufacturing steps (unit operations) related to the drug product quality?

-生產(chǎn)步驟(單元操作)與制劑質(zhì)量有什么關(guān)系？

- How were the critical process parameters identified, monitored, and/or controlled?

-如何識別、監(jiān)測和/或控制關(guān)鍵工藝參數(shù)？

- What is the scale-up experience with the unit operations in this process?

工藝單元中的放大經(jīng)驗是什么？

3.2.P.2.4 Container Closure System包裝系統(tǒng)

What specific container closure attributes are necessary to ensure product performance?

有哪些特定的包裝系統(tǒng)屬性來確保制劑性能？

3.2.P.3 Manufacture生產(chǎn)

- Who manufactures the drug product?

制劑生產(chǎn)場地在哪？

- What are the unit operations in the drug product manufacturing process?

制劑生產(chǎn)工藝的單元操作是什么？

- What is the reconciliation of the exhibit batch?

代表性批準的一致性是什么？

- Does the batch formula accurately reflect the drug product composition? If not, what are the differences and the justifications?

-批次處方是否準確反映了制劑成分？如果不是，有什么區(qū)別和理據(jù)？

- What are the in-process tests and controls that ensure each step is successful?

確保每一步成功，其中控測試是什么？

- What is the difference in size between commercial scale and exhibit batch?

商業(yè)化批次和代表性批次的生產(chǎn)批量差異是什么？

- Does the equipment use the same design and operating principles?

設備是否使用了相同的設備和操作原理

- In the proposed scale-up plan what operating parameters will be adjusted to ensure the product meets all in-process and final product specifications?

-在擬定的放大規(guī)模計劃中，將調(diào)整哪些操作參數(shù)確保制劑符合所有中間產(chǎn)品和最終產(chǎn)品的質(zhì)量標準？

- What evidence supports the plan to scale up the process to commercial scale?

有什么理由支持制劑批量放大至商業(yè)化批量？

3.2.P.4 Control of Excipients輔料控制

What are the specifications for the inactive ingredients and are they suitable for their intended function?

輔料的質(zhì)量標準是什么？它們是否適合輔料的功能？

3.2.P.5 Control of Drug Product制劑質(zhì)量標準

- What is the drug product specification? Does it include all the critical drug product attributes?

制劑質(zhì)量標準是什么？它包括了所有制劑的關(guān)鍵質(zhì)量屬性嗎？

- For each test in the specification, is the analytical method(s) suitable for its intended use and, if necessary, validated? What is the justification for the acceptance criterion?

-對于質(zhì)量標準中的每一項測試，分析方法是否適用傾向于使用，如有必要，進行驗證？接受標準的依據(jù)是什么？

3.2.P.6 Reference Standards and Materials對照品

How were the primary reference standards certified?

初級對照品是如何標化的？

3.2.P.7 Container Closure System包裝系統(tǒng)

What container closure system(s) is proposed for packaging and storage of the drug product? Has the container closure system been qualified as safe for use with this dosage form?

建議使用什么樣的包裝系統(tǒng)來包裝和儲存制 劑？包裝系系統(tǒng)是否可以安全地用于這種劑型？

3.2.P.8 Stability穩(wěn)定性

- What are the specifications for stability studies, including justification of acceptance criteria that differ from the drug product release specification?

穩(wěn)定性研究的接受標準是什么？包裝不同于放行標準的接受標準依據(jù)。

- What drug product stability studies support the proposed shelf life and storage conditions?

什么穩(wěn)定性研究可以用于支持制劑效期和儲存條件？

- What is the post-approval stability protocol?

上市后的穩(wěn)定性方案是什么？

- Any statement/commitment?

有穩(wěn)定性聲明或承諾嗎？