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Technical Committee No |
TC11 |
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Status |
Replaced |
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Category |
Health Sector |
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Sub Category |
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$Resources:StandardType; |
Kuwaiti Standard |
ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.
ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.
ISO 13408-6:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.
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Decision No |
61/2017 |
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Decision By |
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Date of Meeting |
13-03-2017 |
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Approval Date |
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Decision Date |
10-07-2017 |
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Newspaper Publication Date |
23-07-2017 |
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Newspaper Number |
1350 |
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