Uk Mhra Gmp
ENTEROBIOTIX LIMITEDENTEROBIOTIX LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 49464 Insp GMP/IMP 49464/18321324-0004[I]
Record Details
This Uk Mhra Gmp record concerns ENTEROBIOTIX LIMITED, with an inspection on July 26, 2022, issued by the MHRA, covering biologics.
- Company
- ENTEROBIOTIX LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP/IMP
- Inspection date
- July 26, 2022
- Issued
- October 4, 2022
- MIA number
- UK MIA(IMP) 49464
- Site address
- ABERDEEN BLOOD TRANSFUSION CENTRE, FORESTERHILL ROAD, ABERDEEN, AB25 2ZW, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Investigational Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.2 ] Non-sterile investigational medicinal products [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) [ 1.2.1.6 ] Liquids for internal use [ 1.2.1.17 ] Other non-sterile medicinal productsFAECAL MICROBIOTA [ 1.2.2 ] Batch certification [ 1.3 ] Biological investigational medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.6 ] Human or animal extracted products [ 1.3.1.8 ] Other biological medicinal productsFAECAL MICROBIOTA [ 1.5 ] Packaging [ 1.5.1 ] Primary packaging [ 1.5.1.6 ] Liquids for internal use [ 1.5.1.17 ] Other non-sterile medicinal productsFAECAL MICROBIOTA [ 1.5.2 ] Secondary packaging [ 1.6 ] Quality control testing [ 1.6.1 ] Microbiological: sterility
- Restrictions
- Secondary packaging of IMPs is approved for open-label studies only and does not involve labelling for blinded studies.
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ID · b112169b-728d-4431-9f48-d3a053d3afc1
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