Uk Mhra Gmp
AUTOLUS LIMITED THE NUCLEUSAUTOLUS LIMITED THE NUCLEUS – UK MHRA GMP Certificate UK MIA(IMP) 46113 Insp GMP/IMP 46113/34111635-0006[I]
Record Details
This Uk Mhra Gmp record concerns AUTOLUS LIMITED THE NUCLEUS, with an inspection on July 15, 2025, issued by the MHRA, covering biologics.
- Company
- AUTOLUS LIMITED THE NUCLEUS
- Compliance status
- GMPC
- Certificate type
- GMP/IMP
- Inspection date
- July 15, 2025
- Issued
- October 20, 2025
- MIA number
- UK MIA(IMP) 46113
- Site address
- THE NUCLEUS, MARSHGATE, STEVENAGE, SG1 1FR, 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 Special Requirements Live Cells [ 1.1.1.4 ] Small volume liquids Special Requirements Live Cells [ 1.1.1.6 ] Other aseptically prepared productsGene therapies [ 1.1.3 ] Batch certification [ 1.3 ] Biological investigational medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.4 ] Gene therapy products Special Requirements Live Cells [ 1.3.2 ] Batch certification [ 1.3.2.4 ] Gene therapy products Special Requirements Live Cells [ 1.5 ] Packaging [ 1.5.2 ] Secondary packaging [ 1.6 ] Quality control testing [ 1.6.1 ] Microbiological: sterility [ 1.6.2 ] Microbiological: non-sterility [ 1.6.4 ] Biological 2. IMPORTATION OF MEDICINAL PRODUCTS [ 2.3 ] Other Importation Activities [ 2.3.2 ] Importation of Intermediate which undergoes further processing
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ID · c3b559c3-1278-4749-8373-268d329da89b
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