2015年FDA制药质量新指南

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CATEGORY — Pharmaceutical Quality/CMC

• Advancement of Emerging Technology Applications to Modernize the Pharmaceutical
Manufacturing Base
• Appropriate Package Type Terms for Injectable Medical Products Packaged in Multiple-Dose,
Single-Dose, and Single-Patient-Use Containers for Human Use
• Botanical Drug Development
• Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information
• Development of Near Infrared Spectroscopy (NIR) Procedures
• Drug Products Containing Nanomaterials
• Elemental Impurities in Drug Products Marketed in the United States
• Environmental Assessment: Questions and Answers Regarding Drugs with Hormonal Activity
• Established Conditions: Reportable CMC Changes for Approved Drugs and Biologic Products
• Liposome Drug Products: CMC, Human Pharmacokinetic and Bioavailability; and Labeling
Documentation
• Microbiological Quality Consideration in Non-sterile Drug Product Manufacturing
• Quality Metrics and Risk-Based Inspections
• Specified Biotechnology and Specified Synthetic Biological Products – Annual ReportVersion: 06 January 2015 Page | 4

CATEGORY — Pharmaceutical Quality/Manufacturing Standards (CGMP)

• CGMP Data Integrity Questions and Answers
• Current Good Manufacturing Practice for Outsourcing Facilities (Pharmacy Compounding)
• Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities

syhorchid

顶一下

306845830

这个。。。英文太差，看不懂额。。

xhf123456

谢谢分享。