Pharmaceuticals process validation

Biotechnology of Industrial Antibiotics, Erick J. Vandamme Pharmaceutical Process Validation, edited by Bernard T. Loftus and Robert A. Nash... 

Pharmaceutical Process Validation An International Third Edition, Revised and Expanded, edited by Robert A. Nash and Alfred H. Wachter... 

Berry, I.R. and Nash, R., Pharmaceutical Process Validation, Marcel Dekker, New York, 1993. 

Loftus BT, Nash RA, eds. Pharmaceutical Process Validation. New York Marcel Dekker, 1984. 

Pharmaceutical Process Validation An International Third Edition,... 

Pharmaceutical Process Validation Second Edition, Revised and Expanded, edited by Ira R. Berry and Robert A. Nash Ophthalmic Drug Delivery Systems, edited by Ashim K. Mitra Pharmaceutical Skin Penetration Enhancement, edited by Kenneth A. Walters and Jonathan Hadgraft... 

Dedicated to Theodore E. Byers, formerly of the U.S. Food and Drug Administration, and Heinz Sucker, Professor at the University of Berne, Switzerland, for their pioneering contributions with respect to the pharmaceutical process validation concept. We also acknowledge the past contributions of Bernard T. Loftus and Ira R. Berry toward the success of Pharmaceutical Process Validation. 

The third edition of Pharmaceutical Process Validation represents a new approach to the topic in several important respects. 

With the emergence of the pharmaceutical process validation concept, the following four additional steps have been added ... 

Retrospective validation has become synonymous with achieving validation by documenting all the historical information (e.g., release data) for existing products and using that data to support the position that the process is under control. It was originally discussed in a public forum by Meyer [16] and Simms [17]. I also refer the reader to articles in the first edition of Pharmaceutical Process Validation [18]. 

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