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Uk Mhra Gmp
•UNIVERSITY OF EDINBURGH - PET RADIOCHEMISTRY•October 30, 2024

UNIVERSITY OF EDINBURGH - PET RADIOCHEMISTRY – UK MHRA GMP Certificate UK MIA(IMP) 1384 Insp IMP 1384/305937-0014[I]

Record Details

This Uk Mhra Gmp record concerns UNIVERSITY OF EDINBURGH - PET RADIOCHEMISTRY, with an inspection on October 30, 2024, issued by the MHRA, covering drugs.

Company
UNIVERSITY OF EDINBURGH - PET RADIOCHEMISTRY
Compliance status
GMPC
Certificate type
IMP
Inspection date
October 30, 2024
Issued
April 1, 2025
MIA number
UK MIA(IMP) 1384
Site address
QUEENS MEDICAL RESEARCH INSTITUTE, 47 LITTLE FRANCE CRESCENT, EDINBURGH, EH16 4TJ, 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 Special Requirements Radiopharmaceuticals [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms) [ 1.1.2.3 ] Small volume liquids [ 1.1.2.5 ] Other terminally sterilised prepared productsRadiopharmaceuticals [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 1.4.2.3 ] Moist heat [ 1.6 ] Quality control testing [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical 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
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ID · ed321b8a-cbe8-4d3f-93a6-81333b7e50af

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