PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Review
Containment of Material of High Sensitization, High Pharmacological Activity or Toxicity
Shinichi YAMAGAMIMasatoshi TAKEMATAHiroshi MIZOKAMI
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JOURNAL FREE ACCESS

2002 Volume 4 Issue 1 Pages 11-17

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Abstract
  We are engaging the engineering and construction of many pharmaceutical factories, and facing increasing demand for properly treating the substances with the high pharmacological activity or toxicity. After the agreement of ICH Q7A API Guideline, the discussions on several issues including the containment of hazardous substances were raised broadly. Clarifying the requirement for the containment and the provision against the cross contamination was found very difficult. Issues and steps of countermeasures to establish the basis of containment facility obtained through the experience of the engineering and construction of containment facility is described in this report.
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© 2002 Parenteral Drug Association Japan Chapter
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