Uk Mhra Gmp
CLINICAL BIOMANUFACTURING FACILITYCLINICAL BIOMANUFACTURING FACILITY – UK MHRA GMP Certificate UK MIA(IMP) 21584 Insp IMP 21584/89446-0014[I]
Record Details
This Uk Mhra Gmp record concerns CLINICAL BIOMANUFACTURING FACILITY, with an inspection on July 14, 2022, issued by the MHRA, covering biologics.
- Compliance status
- GMPC
- Certificate type
- IMP
- Inspection date
- July 14, 2022
- Issued
- August 10, 2022
- MIA number
- UK MIA(IMP) 21584
- Site address
- OLD ROAD, HEADINGTON, OXFORD, OX3 7JT, 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) [ 1.1.1.1 ] Large volume liquids [ 1.1.1.4 ] Small volume liquids [ 1.1.1.6 ] Other aseptically prepared productsAdjuvants, preparation of aseptic membranes or matrices to air dry vaccines [ 1.2 ] Non-sterile investigational medicinal products [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) [ 1.2.1.5 ] Liquids for external use [ 1.2.1.6 ] Liquids for internal use [ 1.2.2 ] Batch certification [ 1.3 ] Biological investigational medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.1 ] Blood products [ 1.3.1.2 ] Immunological products [ 1.3.1.3 ] Cell therapy products [ 1.3.1.4 ] Gene therapy products [ 1.3.1.5 ] Biotechnology products [ 1.3.1.6 ] Human or animal extracted products [ 1.3.1.8 ] Other biological medicinal productsSiRNA, adjuvants, biological challenge agents [ 1.3.2 ] Batch certification [ 1.3.2.1 ] Blood products [ 1.3.2.2 ] Immunological products [ 1.3.2.3 ] Cell therapy products [ 1.3.2.4 ] Gene therapy products [ 1.3.2.5 ] Biotechnology products [ 1.3.2.6 ] Human or animal extracted products [ 1.3.2.8 ] Other biological medicinal productsSiRNA, adjuvants, biological challenge agents [ 1.4 ] Other products or manufacturing activity [ 1.4.1 ] Manufacture of: [ 1.4.1.3 ] OtherImportation of QP-certified IMPs from a country on the 'approved country for import list' [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 1.5 ] Packaging [ 1.5.2 ] Secondary packaging [ 1.6 ] Quality control testing [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical [ 1.6.4 ] Biological 2. IMPORTATION OF MEDICINAL PRODUCTS [ 2.1 ] Quality control testing of imported medicinal products [ 2.1.2 ] Microbiological: non-sterility [ 2.1.3 ] Chemical/Physical [ 2.1.4 ] Biological [ 2.2 ] Batch certification of imported medicinal products [ 2.2.1 ] Sterile Products [ 2.2.1.1 ] Aseptically prepared [ 2.2.1.2 ] Terminally sterilised [ 2.2.2 ] Non-sterile products [ 2.2.3 ] Biological medicinal products [ 2.2.3.1 ] Blood products [ 2.2.3.2 ] Immunological products [ 2.2.3.3 ] Cell therapy products [ 2.2.3.4 ] Gene therapy products [ 2.2.3.5 ] Biotechnology products [ 2.2.3.6 ] Human or animal extracted products [ 2.2.3.8 ] Other biological medicinal productsSiRNA, adjuvants, biological challenge agents [ 2.3 ] Other Importation Activities [ 2.3.1 ] Site of Physical Importation [ 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
- This was a focused remote inspection following a variation to add oversight process for IMP from listed countries.
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