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Uk Mhra Gmp
•BIOVEX•March 12, 2018

BIOVEX – UK MHRA GMP Certificate UK GMP 31505 Insp GMP 31505/363493-0002[H]

Record Details

This Uk Mhra Gmp record concerns BIOVEX, with an inspection on March 12, 2018, issued by the MHRA, covering biologics.

Company
BIOVEX
Compliance status
GMPC
Certificate type
GMP
Inspection date
March 12, 2018
Issued
May 10, 2018
MIA number
UK GMP 31505
Site address
INCORPORATED, 34 COMMERCE WAY, WOBURN, 01801, 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 [ 1.3.1.4 ] Gene therapy 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 [ 1.5.1 ] Primary packaging [ 1.5.1.6 ] Liquids for internal use [ 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 EU product - Imlygic (EMEA/H/C/002771/0000)
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ID · 7fca41f2-1b2a-4293-82b8-33022cdf2b8d

Other documents for BIOVEX
  • 483 - 2019-09-27September 27, 2019
  • EIR - 2015-02-13February 13, 2015
  • 483 - 2015-02-13February 13, 2015

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