PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Communication to the Editor
Scientific Approach of Process Validaiton
Toshiaki NISHIHATAHisatoshi EMORI
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1999 Volume 1 Issue 1 Pages 53-57

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Abstract

  Process validation is necessary to assure the quality of product and is required for approval of manufacture. Appropriate process validation is achieved by appropriate development of manufacturing process, in-process control and end-point of each process, based on the appropriate design. The development of the manufacturing process, in-process parameter and the end-point must be achieved based on the scientific approach. The sieving method using sonic filtration mechanism could achieve the evaluation of wet granulation progression in a short time and with small sampling amount. This sieving method of wet granule progression was also effective method to determine end-point of the wet-granulation process in a various production scale. Thus, the scientific approach with in-process product seems to be effective to determine the end-point of each process.

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© 1999 Parenteral Drug Association Japan Chapter
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