Under the editorial direction of Berry and Harpaz, a team of 13 industry experts has written the definitive guide to the validation of bulk pharmaceutical chemicals (active pharmaceutical ingredients).
Interpharm Press, Inc.ditorial direction of Berry and Harpaz, a team of 13 industry experts has written the definitive guide to the validation of bulk pharmaceutical chemicals (active pharmaceutical ingredients). This extensive book provides the step-by-step "what to do" and "how to do it" for FDA acceptable validation of BPC manufacture.
While the pharmaceutical industry has concentrated on validation of finished drug products and processes, reality is that the validation of the bulk pharmaceutical chemical, both active pharmaceutical ingredient (API) and excipient, has consumed major portions of FDA thinking. Review of FDA warning letters shows an ever increasing concern with the validation of BPCs. Berry and Harpaz have recognized the need for a thorough, comprehensive and complete book on the "what to" and the "how to."
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