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Pharmaceutical Process Validation: An International Edition (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs) |
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From Book News, Inc. The new edition of this classroom text and desk reference recognizes that pharmaceutical process validation was not an American invention, as many in the field have assumed, but rather that many of the fundamental concepts originated in Switzerland and Germany during the 1980s. The third edition includes new chapters on validation for medical devices, in biotechnology processes, in integrated packaging, and in contract manufacturing, transdermal process valida... >> |
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Validation of Pharmaceutical Processes: Sterile Products |
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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,... >> |
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Analytical Chemistry in a GMP Environment: A Practical Guide |
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From Book News, Inc. Based on the Laboratory Analyst Training and Certification Program, a two-week course developed and implemented by the Johnson and Johnson company, chemists from a range of pharmaceutical companies and a few academic laboratories explain how to comply with the US Food and Drug Administration's Good Manufacturing Practice rules as analytical technologies are changing rapidly. The material is at a level suitable for readers who hold bachelors degrees in chemistry... >> |
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Pharmacology
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