Uk Mhra Gmp
SANOFI PASTEUR INCORPORATEDSANOFI PASTEUR INCORPORATED – UK MHRA GMP Certificate UK GMP 28439 Insp GMP 28439/287401-0001[H]
Record Details
This Uk Mhra Gmp record concerns SANOFI PASTEUR INCORPORATED, with an inspection on September 24, 2018, issued by the MHRA, covering biologics.
- Company
- SANOFI PASTEUR INCORPORATED
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- September 24, 2018
- Issued
- January 8, 2019
- MIA number
- UK GMP 28439
- Site address
- 1 DISCOVERY DRIVE, SWIFTWATER, 18370, 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 [ 1.6.4 ] Biological
- Restrictions
- This certificate relates to the manufacture of Influenza vaccine (and ancillary processes) in buildings 37,(line 2 packaging only), 38, 46, 59. GMP certification for other EU products should refer to GMP certificate issued by EU Supervisory Authority, ANSM. this GMP certificate to be used in parallel with ANSM GMP certification for other areas and products Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products Packaging line 2 in Building 37 approved for influenza packaging Fluzone HD vaccine under assessment at time of inspection
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ID · 15e26c19-934a-432c-83e1-76658deab591
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