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Uk Mhra Gmp
•TEVA PARENTERAL MEDICINES•March 15, 2010

TEVA PARENTERAL MEDICINES – UK MHRA GMP Certificate UK GMP 18796 Insp GMP 18796/404880-0002 [H]

Record Details

This Uk Mhra Gmp record concerns TEVA PARENTERAL MEDICINES, with an inspection on March 15, 2010, issued by the MHRA, covering drugs.

Company
TEVA PARENTERAL MEDICINES
Compliance status
GMPC
Certificate type
GMP
Inspection date
March 15, 2010
Issued
June 8, 2010
MIA number
UK GMP 18796
Site address
INC., 19 HUGHES, IRVINE, 92618-1902, 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) [ 1.1.1.2 ] Lyophilisates [ 1.1.1.4 ] Small volume liquids [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms) [ 1.1.2.3 ] Small volume liquids [ 1.3 ] Biological medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.5 ] Biotechnology products [ 1.3.1.6 ] Human or animal extracted products [ 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 [ 1.6.1 ] Microbiological: sterility [ 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 The inspection covered sterile production activities in building 19 and 21. Visual and automatic Inspection activities in building 13. Warehouse activities in building 23 and 25 and off site at bake parkway.
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ID · 38c6bcd1-e7a7-4b2a-a1e9-cd2c6d47787e

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