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Uk Mhra Gmp
•ASTRAZENECA PHARMACEUTICALS LP•July 9, 2018

ASTRAZENECA PHARMACEUTICALS LP – UK MHRA GMP Certificate UK GMP 12811 Insp GMP 12811/1372867-0008[H]

Record Details

This Uk Mhra Gmp record concerns ASTRAZENECA PHARMACEUTICALS LP, with an inspection on July 9, 2018, issued by the MHRA, covering drugs.

Company
ASTRAZENECA PHARMACEUTICALS LP
Compliance status
GMPC
Certificate type
GMP
Inspection date
July 9, 2018
Issued
September 10, 2018
MIA number
UK GMP 12811
Site address
3001 RED LION ROAD, PHILADELPHIA, 19114, UNITED STATES
Country
UNITED STATES
Products
Human Medicinal Products
Manufacturing operations
1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Products [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) [ 1.1.1.4 ] Small volume liquids [ 1.3 ] Biological medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.2 ] Immunological products [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 1.5 ] Packaging [ 1.5.2 ] Secondary packaging [ 1.6 ] Quality control testing [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products This inspection included the offsite GMP warehouse at 3600 Marshall Lane, Bensalem, PA 19020 USA EU products - Fluenz Tetra and Pandemic Influenza Vaccine H5N1 AstraZeneca
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ID · a93873fd-4d08-4a3f-80da-23cb148ecb22

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