Transcription of DMF 가이드라인 - gmpeye.co.kr
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DMF 가이드라인 - gmpeye.co.kr
Guideline for Drug master Files GU030A gggmmmpppeeeyyyeee 1 DMF (Guideline for Drug master File) Center for Drug Evaluation and Research Food and Drug Administration Department of Health and Human Services September 1989 Guideline for Drug master Files GU030A gggmmmpppeeeyyyeee 2 [ ] I. (INTRODUCTION) II. (DEFINITIONS) III. DMF (TYPES OF DRUG master FILES) IV. DMF (SUBMISSIONS TO DRUG master FILES) (Transmittal Letters) (Original Submissions) (Amendments) (Administrative Information) (Original Submissions) (Amendments) DMF (Drug master File Contents) DMF (Types of Drug master Files) Type I: , , , (Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel) Type II: , , , (Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or)
Guideline for Drug Master Files GU030A ggmmppeeyyee www.gmpeye.co.kr 3 V. DMF 참조 동의(AUTHORIZATION TO REFER TO A DRUG MASTER FILE) V.A. 동의서(Letter of Authorization to FDA)
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