Critical Utilities | Pharma QbD

FDA Guidance for Industry : Manufacturing Biological Intermediates and Biological Drug Substances

The former regulations at 21 CFR 600.11(e)(3) (Ãƒâ€šÃ‚Â§ 600.11(e)(3)) required that all work with spore-bearing microorganisms (spore-formers) be conducted in an entirely separate building, or in a completely walled-off portion of a multiproduct building. The Food and Drug Administration (FDA), modified the regulatory requirements for the manufacturing of biological products with spore-formers to allow greater manufacturing flexibility.

A Rapid and Sensitive UPLC/UV/MS Method for Simvastatin and Lovastatin in Support of Cleaning Validation Studies

The analytical selectivity, sensitivity, and throughput of Waters ACQUITY UPLC Systems enhances cleaning validation studies, resulting in more confidence in results and significant cost savings. UPLC enables manufacturing plants to move through production batches faster, increasing productivity and efficiency. After completing the registration form you will have access to download the white paper in pdf format.