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KMID : 1142220100050010073
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Regulatory Research on Food, Drug & Cosmetic
2010 Volume.5 No. 1 p.73 ~ p.81
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Study on the Guideline for the DrugEquivalenceTest according to the Manufacturing Process Changes
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Cho Il-Yong
Han Eui-Sik
Jung Ju-Yeon
Lee Rhee-Da
Song Yun-Kyoung
Kim Dong-Sub
Kim Jung-Hyun
Song Young-Mi
Park Sang-Aeh
Chung Soo-Youn
Lee Sun-Hee
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Abstract
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This guidance for post approval manufacturing changes which include manufacturing process changes, manufacturing equipment changes and site changes has been requested, so we reviewed related regulations, guidelines and domestic and foreign cases for post approval manufacturing changes. We finalized this guidance based on the related documents and various kinds of opinions, which we collected, with the task force team. The guidance provides recommendations to pharmaceutical sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes such as manufacturing process changes, manufacturing equipment changes and site changes. Also, this guidance defines levels of changes, recommended in vitro dissolution tests or in vivo bioequivalence test for each level of change and documentation that should support for the change. We published the manufacturing equipment addendum providing the information about the design and operating principles of manufacturing equipment for easier access to the change of manufacturing equipment. We believe that this guidance will be useful for applicants to prepare documentation in support of the post approval changes in both NDAs and ANDAs. In addition, the guidance will help the scientific officers in KFDA for reviewing application documents efficiently. Furthermore, we can secure the safety and efficacy of drug products through appropriately post manufacturing change management using the guidance.
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KEYWORD
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manufacturing process, manufacturing equipment, manufacturing site, pharmaceutical equivalence
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