Design of Experiments to Establish Temperature （试验设计建立温度）.pdfVIP

Design of Experiments to Establish Temperature and Humidity Limits for Temperature Excursions during Product Distribution William R. Porter The 34th Annual Midwest Biopharmaceutical Statistics Workshop Muncie, IN May 24, 2011 Why is this an issue? • Pharmaceutical manufacturers face increasing regulatory pressure to provide data to support claims that product quality is unaffected by transient temperature and humidity extremes encountered during storage, distribution and end use outside of storage conditions stated on the label. Alternative is to use expensive packaging and stringent shipping control measures. MBSW 5/24/2011 Copyright 2011 W. R. Porter 2 Example: European Medicines Agency • Concept paper on Storage Conditions during Transport:  ―The goal is to create new Good Distribution Practice (GDP) and GMP guidance and may lead to the need to revise the guideline on declaration of storage conditions (CPMP/QWP/609/96/Rev2). This current guidance was written in 1996 and revised in 2003, during this time significant changes continued to occur in the globalisation of manufacture with a consequent increase in the complexity and vulnerability in the supply chain, leading to a lack of clear guidance on the regulatory expectations for ensuring that medicinal products and APIs are not damaged during transportation.‖ [emphasis added] MBSW 5/24/2011 Copyright 2011 W. R. Porter 3 Example: Health Canada • Health Products and Food Branch Inspectorate GUIDE-0069 Guid