药品质量标准USP
合集下载
相关主题
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
Section 201(j):
• The term “official compendium” means the official United States Pharmacopeia . . . National Formulary, or any supplement . . .” 术语“official compendium” 意思是法定美国药典…国家处方集及其增补本…
FDFoDcuCmAeRnetaqruyirSetmanendta资s料r仅df供o参s考r,不当C之处o，请n联系f改o正。rmance to USP
• Ultimately, the product must conform to the compendial standard. 最终，制剂产品必须符合药典标准。
– cGMP regulations require testing of each batch of finished drug product to ensure that it meets defined specifications. cGMP法规要求最终产品每批检测，以保证产品符合既定的标准
– FDA will always use the compendial method as the “referee test.” USP is “regulatory analytical procedure” FDA总是使用药典方法作为“仲裁方法”。USP是“法定分析方法”
ORA, CPG Sec. 420.400 Βιβλιοθήκη Baiduerformance of Tests for Compendial Requirements on Compendial Products (CPG 7132.05)
– Includes requirements for approval to market a drug 包括对药品上市批准的要求
– Portions relevant to USP also apply to biologics 涉及USP的部分同样适用于生物制品
• FDA regulations FDA的法规
资料仅供参考,不当之处，请联系改正。
美国与药品标准相关 的法律
US Drug Law资料仅供参考,不当之处，请联系改正。
• Federal Food, Drug, and Cosmetic Act (FFDCA) 联邦食品药品化妆品法
– Basic text that governs all pharmaceutical, medical device, food, cosmetics, dietary supplements 管理药品、医疗器械、食品、化妆品和膳食补充剂的基本法律
Section 501(a)(2)(B):
• A drug is adulterated if it is not manufactured in accordance with current Good Manufacturing Practices (cGMPs) 若药品未按照cGMP规范生产视为假药
– USP-NF method must be used if the company has committed to FDA to use it, or if it is the only appropriate test 以下情况必须使用USP-NF方法：如果生产商向FDA承诺使用，或者USP-NF的方法 是唯一恰当的方法
Section 501(b):
• A drug is adulterated “if it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium…” 以下情况判为假药 “其声称为药典收录的药品名称，而其效力不同于、或其质 量或纯度低于药典中所设定的标准。对效力、质量或纯度的判断应当根据药典 中所设定的分析方法或测试而得到……”
• “Scientifically sound.” “科学合理.”
– Manufacturer must assure conformance to USP standard “by suitable means, including adequate manufacturing process validation and control.” 生产商必须“通过恰当的方式，包括充分的生产工艺验证和控制”保证符合USP标准 。
– In other cases, manufacturers can use an alternative test method if it is: 其他情况下生产商可以使用替代方法，如果（替代方法）：
• At least as stringent as the compendial method and 至少和药典方法一样严格，并且
– Developed by FDA under authority granted by FFDCA 在FFDCA法律框架下由FDA建立
• FDA guidance FDA指南
– Non-binding, but indicates FDA’s thinking 非法规，但体现FDA的考虑
Recognition of USP i资n料仅F供参F考,D不当之C处，A请联系–改正D。 ocumentary Standards
• The term “official compendium” means the official United States Pharmacopeia . . . National Formulary, or any supplement . . .” 术语“official compendium” 意思是法定美国药典…国家处方集及其增补本…
FDFoDcuCmAeRnetaqruyirSetmanendta资s料r仅df供o参s考r,不当C之处o，请n联系f改o正。rmance to USP
• Ultimately, the product must conform to the compendial standard. 最终，制剂产品必须符合药典标准。
– cGMP regulations require testing of each batch of finished drug product to ensure that it meets defined specifications. cGMP法规要求最终产品每批检测，以保证产品符合既定的标准
– FDA will always use the compendial method as the “referee test.” USP is “regulatory analytical procedure” FDA总是使用药典方法作为“仲裁方法”。USP是“法定分析方法”
ORA, CPG Sec. 420.400 Βιβλιοθήκη Baiduerformance of Tests for Compendial Requirements on Compendial Products (CPG 7132.05)
– Includes requirements for approval to market a drug 包括对药品上市批准的要求
– Portions relevant to USP also apply to biologics 涉及USP的部分同样适用于生物制品
• FDA regulations FDA的法规
资料仅供参考,不当之处，请联系改正。
美国与药品标准相关 的法律
US Drug Law资料仅供参考,不当之处，请联系改正。
• Federal Food, Drug, and Cosmetic Act (FFDCA) 联邦食品药品化妆品法
– Basic text that governs all pharmaceutical, medical device, food, cosmetics, dietary supplements 管理药品、医疗器械、食品、化妆品和膳食补充剂的基本法律
Section 501(a)(2)(B):
• A drug is adulterated if it is not manufactured in accordance with current Good Manufacturing Practices (cGMPs) 若药品未按照cGMP规范生产视为假药
– USP-NF method must be used if the company has committed to FDA to use it, or if it is the only appropriate test 以下情况必须使用USP-NF方法：如果生产商向FDA承诺使用，或者USP-NF的方法 是唯一恰当的方法
Section 501(b):
• A drug is adulterated “if it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium…” 以下情况判为假药 “其声称为药典收录的药品名称，而其效力不同于、或其质 量或纯度低于药典中所设定的标准。对效力、质量或纯度的判断应当根据药典 中所设定的分析方法或测试而得到……”
• “Scientifically sound.” “科学合理.”
– Manufacturer must assure conformance to USP standard “by suitable means, including adequate manufacturing process validation and control.” 生产商必须“通过恰当的方式，包括充分的生产工艺验证和控制”保证符合USP标准 。
– In other cases, manufacturers can use an alternative test method if it is: 其他情况下生产商可以使用替代方法，如果（替代方法）：
• At least as stringent as the compendial method and 至少和药典方法一样严格，并且
– Developed by FDA under authority granted by FFDCA 在FFDCA法律框架下由FDA建立
• FDA guidance FDA指南
– Non-binding, but indicates FDA’s thinking 非法规，但体现FDA的考虑
Recognition of USP i资n料仅F供参F考,D不当之C处，A请联系–改正D。 ocumentary Standards