Uk Mhra Gmp
MEDIMMUNE LTD (PART OF THE ASTRAZENECA GROUP)MEDIMMUNE LTD (PART OF THE ASTRAZENECA GROUP) – UK MHRA GMP Certificate UK MIA(IMP) 16209 Insp IMP 16209/476867-0013[I]
Record Details
This Uk Mhra Gmp record concerns MEDIMMUNE LTD (PART OF THE ASTRAZENECA GROUP), with an inspection on February 17, 2025, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- IMP
- Inspection date
- February 17, 2025
- Issued
- February 17, 2025
- MIA number
- UK MIA(IMP) 16209
- Site address
- AARON KLUG BUILDING, GRANTA PARK, GREAT ABINGTON, CAMBRIDGE, CB21 6ET, 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 [ 1.3.2.8 ] Other biological medicinal productsBiological active starting materials(when required by national legislation) 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 [ 2.2.3.8 ] Other biological medicinal productsBiological active starting materials(when required by national legislation) [ 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
- 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 · b7c41b53-0f92-434d-acca-b62520ce28b8
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