The ISPE Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) provides a scientific risk-based approach based on ICH Q9 to manage the risk of cross-contamination to maintain product quality and operator safety. This allows the selection of the appropriate risk control strategies to be implemented on a case-by-case basis to maintain patient safety and assure product quality.
Product Details
Edition: 1st Published: 09/01/2010 ISBN(s): 1931879974 Number of Pages: 186