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Uk Mhra Gmp
•AUTOLUS LIMITED MODULE 7•March 24, 2021

AUTOLUS LIMITED MODULE 7 – UK MHRA GMP Certificate UK MIA(IMP) 46113 Insp IMP 46113/19765965-0002[I]

Record Details

This Uk Mhra Gmp record concerns AUTOLUS LIMITED MODULE 7, with an inspection on March 24, 2021, issued by the MHRA, covering biologics.

Company
AUTOLUS LIMITED MODULE 7
Compliance status
GMPC
Certificate type
IMP
Inspection date
March 24, 2021
Issued
May 11, 2021
MIA number
UK MIA(IMP) 46113
Site address
MODULE 7, 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) [ 1.1.1.4 ] Small volume liquids [ 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 [ 1.6.4 ] 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 · 97c24614-e114-459c-a6cb-b90bf3076ed1

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