Uk Mhra Gmp
NOVARTIS PHARMACEUTICALS UK LIMITEDNOVARTIS PHARMACEUTICALS UK LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 101 Insp GMP/IMP 101/19062596-0012[I]
Record Details
This Uk Mhra Gmp record concerns NOVARTIS PHARMACEUTICALS UK LIMITED, with an inspection on May 1, 2025, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP/IMP
- Inspection date
- May 1, 2025
- Issued
- May 1, 2025
- MIA number
- UK MIA(IMP) 101
- Site address
- 2ND FLOOR, THE WEST WORKS BUILDING, WHITE CITY PLACE, 195 WOOD LANE, LONDON, W12 7FQ, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Investigational Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Investigational Medicinal Products [ 1.1.3 ] Batch certification [ 1.2 ] Non-sterile investigational medicinal products [ 1.2.2 ] Batch certification [ 1.3 ] Biological investigational medicinal products [ 1.3.2 ] Batch certification [ 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 productsStandard fermentation Biological Products 2. IMPORTATION OF MEDICINAL PRODUCTS [ 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 [ 2.2.3.2 ] 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 productsStandard fermentation Biological Products [ 2.3 ] Other Importation Activities [ 2.3.4 ] Other1) The Importation of Radiopharmaceuticals/Radionuclide generators. 2) Importation of QP certified IMPs from a country on the approved country for import list.
- Restrictions
- This certificate is issued based on a desk-based assessment of GMP compliance information provided by the manufacturer. This certificate should be used in combination with the relevant authorisation/registration. A risk-based site inspection programme remains in force.
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ID · a26923a3-eb25-43de-be07-2d1972f2589f
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