WHO最近發(fā)布的《生物制品變更指南》中提及藥典標(biāo)準(zhǔn)變更，其分類原則同樣適用于藥品：
原料藥
(for biotherapeutics) Change in the standard/monograph (that is, specifications) claimed for the drug substance, involving the following:
（生物治療）原料藥標(biāo)準(zhǔn)/專論（即標(biāo)準(zhǔn)）變更，涉及以下情況：
A change from a pharmacopoeial standard/monograph to an in-house standard
從藥典標(biāo)準(zhǔn)/專著變更為內(nèi)部標(biāo)準(zhǔn)
Reporting category
Moderate
中等
Supporting data
支持性數(shù)據(jù)
1. Revised drug product labelling information, as applicable.
如適用，修訂藥品標(biāo)簽信息。
2. Updated copy of the proposed drug substance specifications.
更新的擬議藥物物質(zhì)規(guī)范副本。
3. Where an in-house analytical procedure is used and a pharmacopoeial standard/monograph is claimed, results of an equivalency study between the in-house and pharmacopoeial methods.
如果采用內(nèi)部分析程序并聲稱有藥典標(biāo)準(zhǔn)/專著，則是內(nèi)部方法與藥典方法之間的等效性研究結(jié)果。
4. Copies or summaries of validation reports if new analytical procedures are used.
如采用了新的分析程序，驗(yàn)證報(bào)告的副本或摘要。
5. Justification of specifications with data.
用數(shù)據(jù)來(lái)證明規(guī)范的合理性。
A change from an in-house standard to a pharmacopoeial standard/monograph or from one pharmacopoeial standard/ monograph to a different pharmacopoeial standard/monograph
從內(nèi)部標(biāo)準(zhǔn)變更為藥典標(biāo)準(zhǔn)/專論，或從一種藥典標(biāo)準(zhǔn)/專論變更為另一種不同的藥典標(biāo)準(zhǔn)/專論
Conditions to be fulfilled
需滿足的條件
1. The change is made exclusively in order to comply with a pharmacopoeial monograph.
變更僅為符合藥典專論。
2. There is no change in drug substance specifications outside the approved ranges.
原料藥標(biāo)準(zhǔn)未超出批準(zhǔn)范圍。
3. There is no deletion of tests or relaxation of acceptance criteria of the approved specifications, except to comply with a pharmacopoeial standard/monograph.
除符合藥典標(biāo)準(zhǔn)/專論外，不刪除測(cè)試或放寬已批準(zhǔn)的接受標(biāo)準(zhǔn)。
4. There are no deletions or changes to any analytical procedures, except to comply with a pharmacopoeial standard/monograph.
除符合藥典標(biāo)準(zhǔn)/專論外，不對(duì)任何分析方法進(jìn)行刪除或變更。
Reporting category
變更分類
Minor
微小
Supporting data
支持性數(shù)據(jù)
1. Revised drug product labelling information, as applicable.
如適用，修訂藥品標(biāo)簽信息。
2. Updated copy of the proposed drug substance specifications.
更新的擬議原料藥標(biāo)準(zhǔn)副本。
3. Where an in-house analytical procedure is used and a pharmacopoeial standard/monograph is claimed, results of an equivalency study between the in-house and pharmacopoeial methods.
如果采用內(nèi)部分析程序并聲稱有藥典標(biāo)準(zhǔn)/專著，則是內(nèi)部方法與藥典方法之間的等效性研究結(jié)果。
Change in the specifications for the drug substance in order to comply with an updated pharmacopoeial standard/monograph
為符合更新后的藥典標(biāo)準(zhǔn)/專論，調(diào)整原料藥標(biāo)準(zhǔn)
Conditions to be fulfilled
需滿足的條件
1. The change is made exclusively in order to comply with a pharmacopoeial monograph.
變更僅為符合藥典專論。
2. There is no change in drug substance specifications outside the approved ranges.
原料藥標(biāo)準(zhǔn)未超出批準(zhǔn)范圍。
Reporting category
變更分類
Minor
微小
Supporting data
支持性數(shù)據(jù)
1. Revised drug product labelling information, as applicable.
如適用，修訂藥品標(biāo)簽信息。
2. Updated copy of the proposed drug substance specifications.
更新的擬議原料藥標(biāo)準(zhǔn)副本。
制劑
Change in the standard/monograph (that is, specifications) claimed for the drug product, involving the following:
藥品標(biāo)準(zhǔn)/專論（即標(biāo)準(zhǔn)）變更，涉及以下內(nèi)容：
a. A change from a pharmacopoeial standard/monograph to an in-house standard
從藥典標(biāo)準(zhǔn)/專論變更為內(nèi)部標(biāo)準(zhǔn)
Reporting category
變更分類
Moderate
中等
Supporting data
支持性數(shù)據(jù)
1. Revised drug product labelling information, as applicable.
修訂藥品標(biāo)簽信息（如適用）。
2. An updated copy of the proposed drug product specifications.
擬議藥品標(biāo)準(zhǔn)的更新副本。
3. Where an in-house analytical procedure is used and a pharmacopoeial standard/monograph is claimed, results of an equivalency study between the in-house and pharmacopoeial methods.
如果采用內(nèi)部分析程序并聲明藥典標(biāo)準(zhǔn)/專論，則應(yīng)分析內(nèi)部方法與藥典方法之間的等效性研究。
4. Copies or summaries of validation reports if new analytical procedures are used.
如采用了新的分析程序，提供驗(yàn)證報(bào)告的副本或摘要。
5. Justification of specifications with data.
用數(shù)據(jù)證明標(biāo)準(zhǔn)的合理性。
A change from an in-house standard to a pharmacopoeial standard/monograph or from one pharmacopoeial standard/ monograph to a different pharmacopoeial standard/monograph
從內(nèi)部標(biāo)準(zhǔn)變更為藥典標(biāo)準(zhǔn)/專論，或從一種藥典標(biāo)準(zhǔn)/專論變更為另一種藥典標(biāo)準(zhǔn)/專論
Conditions to be fulfilled
需滿足的條件
1. The change is made exclusively to comply with a pharmacopoeial monograph.
此變更僅為符合藥典專論的要求。
2. There is no change in drug product specifications outside the approved ranges.
藥品標(biāo)準(zhǔn)未超出批準(zhǔn)范圍。
3. There is no deletion of tests or relaxation of acceptance criteria of the approved specifications, except to comply with a pharmacopoeial standard/monograph.
除符合藥典標(biāo)準(zhǔn)/專論外，不刪除測(cè)試或放寬已批準(zhǔn)的接受標(biāo)準(zhǔn)。
4. There is no deletion or change to any analytical procedures, except to comply with a pharmacopoeial standard/monograph.
除了符合藥典標(biāo)準(zhǔn)/專論外，分析程序不被刪除或變更。
Reporting category
變更分類
Minor
微小
Supporting data
支持性數(shù)據(jù)
1. Revised drug product labelling information, as applicable.
修訂藥品標(biāo)簽信息（如適用）。
2. An updated copy of the proposed drug product specifications.
擬議藥品標(biāo)準(zhǔn)的更新副本。
3. Where an in-house analytical procedure is used and a pharmacopoeial standard/monograph is claimed, results of an equivalency study between the in-house and pharmacopoeial methods.
如果采用內(nèi)部分析程序并聲明藥典標(biāo)準(zhǔn)/專論，則應(yīng)分析內(nèi)部方法與藥典方法之間的等效性研究。
Change in the specifications for the drug product to comply with an updated pharmacopoeial standard/monograph
藥品標(biāo)準(zhǔn)變更以符合藥典標(biāo)準(zhǔn)/專論更新
Conditions to be fulfilled
需滿足的條件
1. The change is made exclusively to comply with a pharmacopoeial monograph.
此變更僅為符合藥典專論的要求。
2. There is no change in drug product specifications outside the approved ranges.
藥品標(biāo)準(zhǔn)未超出批準(zhǔn)范圍。
Reporting category
變更分類
Minor
微小
Supporting data
支持性數(shù)據(jù)
1. Revised drug product labelling information, as applicable.
修訂藥品標(biāo)簽信息（如適用）。
2. An updated copy of the proposed drug product specifications.
擬議藥品標(biāo)準(zhǔn)的更新副本。
3. Where an in-house analytical procedure is used and a pharmacopoeial standard/monograph is claimed, results of an equivalency study between the in-house and pharmacopoeial methods.
如果采用內(nèi)部分析程序并聲明藥典標(biāo)準(zhǔn)/專論，則應(yīng)分析內(nèi)部方法與藥典方法之間的等效性研究。
Change in the standard/monograph (that is, specifications) claimed for the excipient
變更輔料標(biāo)準(zhǔn)/專論（即標(biāo)準(zhǔn)）
Reporting category
變更分類
Moderate
中等
Supporting data
支持性數(shù)據(jù)
1. Updated excipient specifications.
更新后的輔料標(biāo)準(zhǔn)。
2. Where a House analytical procedure is used and a pharmacopoeial/compendial standard/monograph is claimed, results of an equivalency study between the House and compendial methods.
如采用內(nèi)部分析程序并聲明藥典/匯編標(biāo)準(zhǔn)/專論，應(yīng)分析等效性。
3. Justification of the proposed excipient specifications (for example, demonstration of the suitability of the monograph to control the excipient and potential impact on the performance of the drug product).
擬議輔料標(biāo)準(zhǔn)的合理性（例如，證明該標(biāo)準(zhǔn)適合控制輔料及其對(duì)藥品性能的潛在影響）。
4. A declaration that consistency of quality and of the production process of the excipient is maintained.
聲明輔料的質(zhì)量和生產(chǎn)過(guò)程保持一致性。
Change in the standard/monograph (that is, specifications) claimed for the excipient
變更輔料標(biāo)準(zhǔn)/專論（即標(biāo)準(zhǔn)）
Conditions
條件
1. The change is from a House standard to a pharmacopoeial standard/monograph.
變更內(nèi)容為內(nèi)部標(biāo)準(zhǔn)變更為藥典標(biāo)準(zhǔn)/專論。
2. The change is made exclusively to comply with a pharmacopoeial standard/monograph.
此變更僅為符合藥典標(biāo)準(zhǔn)/專論
3. There is no change to the specifications for the functional properties of the excipient outside the approved ranges, and no change that results in a potential impact on the performance of the drug product.
輔料功能性標(biāo)準(zhǔn)在批準(zhǔn)范圍內(nèi)，也沒(méi)有任何可能影響藥品性能的變動(dòng)。
4. There is no deletion of tests or relaxation of acceptance criteria of the approved specifications, except to comply with a pharmacopoeial standard/monograph.
除符合藥典標(biāo)準(zhǔn)/專論外，不刪除測(cè)試或放寬已批準(zhǔn)的接受標(biāo)準(zhǔn)。
5. There is no deletion or change to any analytical procedures, except to comply with a pharmacopoeial standard/monograph.
除符合藥典標(biāo)準(zhǔn)/專論外，不刪除或更改分析程序。
Reporting category
變更分類
Minor
微小
Supporting data
支持性數(shù)據(jù)
1. Updated excipient specifications.
更新后的輔料標(biāo)準(zhǔn)。
2. Where a House analytical procedure is used and a pharmacopoeial/compendial standard/monograph is claimed, results of an equivalency study between the House and compendial methods.
如采用內(nèi)部分析程序并聲明藥典/匯編標(biāo)準(zhǔn)/專論，應(yīng)分析等效性。
3. Justification of the proposed excipient specifications (for example, demonstration of the suitability of the monograph to control the excipient and potential impact on the performance of the drug product).
擬議輔料標(biāo)準(zhǔn)的合理性（例如，證明該標(biāo)準(zhǔn)適合控制輔料及其對(duì)藥品性能的潛在影響）。
4. A declaration that consistency of quality and of the production process of the excipient is maintained.
聲明輔料的質(zhì)量和生產(chǎn)過(guò)程保持一致性。
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