Tag «Compliance Insight»

How Fda’s New Guidelines Help Reduce Cross-contamination In Pharmacy And Bio-tech Industries

The FDA report ‘Pharmaceutical Quality for the 21st Century: A Risk-Based Approach’ lays emphasis on the Quality-by-design approach for process validation. It includes Process Development, Process Analytical Technologies, and Corrective and Preventive Actions (CAPA). Michael R. Goodman, compliance specialist, Compliance Insight that these new guidelines for validation in Current Goods Manufacturing Processes (cGMP) specifically help …