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無菌產品 難以檢測之產品與USP790

#1
露比 發表於 2019 / 05 / 23
您好, 關於無菌產品 難以檢測之產品與USP790, 有兩個問題想要請教 1 已經取得許可並已上市的產品,也必須遵從USP790嗎? 或是由廠內自行評估是否需要呢? 或是另有其他規定? 2 除了無菌產品的成品以外, 原料藥API也需要遵從USP790嗎? 謝謝您
管理員回覆
1.如出口國家要求或產品規格為依據USP標準建立時,皆須遵守USP790之規範;TR79提及部分製造商未依循USP790,可能原因是其產品未於美國上市。
 
TR79 section 3.1 PDA Survey on DIP Products
“Many firms (52%) do not currently comply with the requirement to conduct supplemental destructive testing on DIP products as described in USP <790> and <1> (1,4). This may be due, in part, to the geographic distribution of the respondents that do not distribute product in the United States.”
2.USP790適用於”最終產品”,原料API不再其範疇內;但TR79提到API的異物管制為產品生命週期管理環節的一部分,API製造者應進行相關管制,且其管制標準應高於於最終產品之標準。
 
UPS790:
“Where used in this chapter, the term essentially free means that when injectable drug products are inspected as described herein, no more than the specified number of units may be observed to contain visible particulates”
 
 
TR79:
Section 3.2 Lifecycle management
“A key message taken from the PDA 2015 Particulate Matter in DIPs survey is that the industry as a whole must begin to take planned short- and long-term actions to develop lifecycle control processes for DIP products, focusing on API, raw materials, components, and in-process fill/finish controls.”
 
Section 6.0 Defect Prevention: A Lifecycle Approach
“For DIP products, the focus should be on API, raw material, primary packaging component, supplier, and in-process fill/finish controls. Tis becomes more critical if formulations cannot be terminally filtered prior to filling.”
 
Section 6.1 APIs
“API suppliers should apply particulate controls in their processes and make available the control test data for each lot of material.”
 
Section 7.0 Conclusion
“Limits on particulate levels from the upstream materials or steps must be more stringent than the expected finished product outgoing quality.”


From TPDA
2018/06/27

 

 

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