Complying and Applying USP <1079> "Good Storage and Shipping Practices"
With the overwhelming complexity of assuring product integrity throughout the entire distribution chain, the stability of the product is of paramount concern as it moves through the chain of custody. In this presentation Mary Foster PhD, USP Packaging and Storage Expert Committee Member, US Pharmacopeia (USP),
- Understanding the role of the USP within the industry and the latest information regarding standard
- Outlining the new 1079 chapters for implementation
- Understanding 1079’s definition for validation (for packaging) and comparing to other industry standard guidelines
- Packaging, storage and distribution
- Container processes and requirements
- Overview of evidence gathered
- Uncovering new guidelines
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Presented at Pharma IQ's 8th Cold Chain Management and Temperature Control Summit in February 2010.