PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
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The Future Concept of Pharmaceutical Manufacturing Plant and Manufacturing Control
Kunio KAWAMURA
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JOURNALS FREE ACCESS

1999 Volume 1 Issue 1 Pages 9-17

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Abstract

  There are various academic associations related to pharmaceutical sciences and technology, most of which are dealing with pharmaceuticals themselves. The focussed areas are to synthesize new chemical entities, to find new pharmacological or therapeutic effects, and to develop new dosage forms. Relatively few researches have been reported on the area of manufacturing process, although there have been various researches and studies have been performed, particularly since the time of introduction of the concept of validation. This would be attributed to the lack of appropriate JOURNAL which enables the active information exchange possible. The journal newly published by Japan PDA would encourage persons who are engaging manufacturing plant, development engineering, quality laboratory and also who are engaging in regulatory inspections. As some examples of subjects which are expected to be contributed to the Japan PDA Journal relating to the future concept of manufacturing plant and manufacturing control, several topics are introduced. In the future manufacturing plant, 1) environment controlled area would become limited area which is as small as necessary, which becomes possible by applying isolator system or barrier system. Even the classification of cleanliness would become different one in future, along with the study of air flow dynamics as well as the application of isolator system. 2) Application of Luciferin-Luciferase-Chemo-luminance, method of microbial control would make the current air borne microbes control method different one and to make more quick in getting result and feed back to the process. 3) Continuous and automatic monitoring of air borne particulate would make more strict control and more quick action possible. 4) Systematic analysis of various data obtained from the monitoring of water would make correlation among various specifications more clear. As the results, continuous automatic in-line monitoring of water system by using conductivity, TOC, pH, and particulate matter might be enough to assure the quality of water, after the accumulation of quality data. As an example, it might be revealed that TOC value of 25 ppb or less shows endotoxin of 0.25 EU/ml or less. UF membrane would be used more frequently, since it endures high pressure steam sterilization. 5) Hydrogen peroxide sterilization would be more frequently be used according to the development and application of gas monitoring system. Submission of such papers and active discussion would make the pharmaceutical industry active and regulatory agencies would be able to have sound scientific basis on each operation.

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© 1999 Parenteral Drug Association Japan Chapter
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