Uk Mhra Gmp
AUTOLUS LTDAUTOLUS LTD – UK MHRA GMP Certificate UK MIA(IMP) 46113 Insp IMP 46113/19356524-0001[I]
Record Details
This Uk Mhra Gmp record concerns AUTOLUS LTD, with an inspection on July 21, 2020, issued by the MHRA, covering biologics.
- Company
- AUTOLUS LTD
- Compliance status
- GMPC
- Certificate type
- IMP
- Inspection date
- July 21, 2020
- Issued
- September 9, 2020
- MIA number
- UK MIA(IMP) 46113
- Site address
- MODULE 4, CELL & GENE THERAPY CATAPULT MANUFACTURING CENTRE, GUNNELS WOOD ROAD, STEVENAGE, SG1 2FX, 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 Special Requirements Live Cells [ 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 [ 1.6.4 ] Biological 2. IMPORTATION OF MEDICINAL PRODUCTS [ 2.3 ] Other Importation Activities [ 2.3.2 ] Importation of Intermediate which undergoes further processing
- Restrictions
- Secondary Packaging is only approved for Open label kits. The randomisation or blinded labelling of kits is not allowed. This certificate is issued based on a remote inspection of GMP compliance during COVID-19 travel restrictions. A risk-based site inspection programme remains in force.
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ID · e06fc8ee-c7d1-4785-8d56-c33734ef0e7d
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