Release Date: 01 November, 1998
Hardcover
|
From Book News, Inc.
Revised and expanded from the 1986 . Provides a detailed, single-source reference for designing, qualifying, calibrating, certifying, and validating systems required to prepare aseptic and non-aseptic pharmaceutical products. Compiles compliance and regulatory principles, documentation practices, scientific approaches, and engineering concepts that can be used independently or in combination to validate products, processes, and equipment. Among the topics are facility design, monitoring non-viable particles, validating utilities, steam sterilization-in-place technology, sterilizing-grade filters, preparing components, packaging operations, and process control and quality systems. Book News, Inc.®, Portland, OR
American Journal of Pharmaceutical Education
Reviewer Praise for the Previous Edition! "...easy to read and informative....an excellent blend of theoretical knowledge and applied practical considerations."
Irish Pharmacy Journal
"... useful to those designing a facility for producing sterile and nonsterile products...a good mix of the theoretical and applied."
Pharmatimes
"...an excellent presentation on the subject of validation of pharmaceutical processes related to sterile products."
Pharmaceutical Development and Technology
"...overwhelmingly valuable to anyone who has anything at all to do with the manufacture of sterile products." Rating 2.0
Validation of medical devices?I was looking for more information on medical devices than was provided and greater detail on the statistical methodology used to validate which was especially sketchy, especially at such a steep price. |
|
