Uk Mhra Gmp
ZAYED CENTRE FOR RESEARCH INTO RARE DISEASE IN CHILDRENZAYED CENTRE FOR RESEARCH INTO RARE DISEASE IN CHILDREN – UK MHRA GMP Certificate UK MIA(IMP) 17328 Insp IMP 17328/23930512-0005[I]
Record Details
This Uk Mhra Gmp record concerns ZAYED CENTRE FOR RESEARCH INTO RARE DISEASE IN CHILDREN, with an inspection on May 24, 2023, issued by the MHRA, covering biologics.
- Compliance status
- GMPC
- Certificate type
- IMP
- Inspection date
- May 24, 2023
- Issued
- October 15, 2023
- MIA number
- UK MIA(IMP) 17328
- Site address
- 20 GUILFORD STREET, LONDON, WC1N 1DZ, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Investigational Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Investigational Medicinal Products [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) [ 1.1.1.4 ] Small volume liquids [ 1.1.3 ] Batch certification [ 1.3 ] Biological investigational medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.3 ] Cell therapy products [ 1.3.1.4 ] Gene therapy productsViral vectors [ 1.3.2 ] Batch certification [ 1.3.2.3 ] Cell therapy products [ 1.3.2.4 ] Gene therapy productsViral vectors [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 1.5 ] Packaging [ 1.5.2 ] Secondary packaging 2. IMPORTATION OF MEDICINAL PRODUCTS [ 2.3 ] Other Importation Activities [ 2.3.2 ] Importation of Intermediate which undergoes further processing [ 2.3.4 ] OtherImportation of QP-certified IMPs from a country on the approved country for import list
- Restrictions
- GOSH ZCR operations restricted to Grade C rooms with isolator or closed manufacture IMP importation activities restricted to supplies directly into the licenced GOSH facility(not supply to other facilities or 3rd party sites)
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ID · 3c218542-d807-4fdf-ac7c-9e3e84f64825
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