Uk Mhra Gmp
WYETH PHARMACEUTICALS DIVISION OF WYETH HOLDINGS CORPORATIONWYETH PHARMACEUTICALS DIVISION OF WYETH HOLDINGS CORPORATION – UK MHRA GMP Certificate UK GMP 6268 Insp GMP 6268/1704972-0014[H]
Record Details
This Uk Mhra Gmp record concerns WYETH PHARMACEUTICALS DIVISION OF WYETH HOLDINGS CORPORATION, with an inspection on December 10, 2018, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- December 10, 2018
- Issued
- March 1, 2019
- MIA number
- UK GMP 6268
- Site address
- A SUBSIDIARY OF PFIZER INC, 4300 OAK PARK, SANFORD, 27330, 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) [ 1.1.1.6 ] Other aseptically prepared productsDrug Substance [ 1.2 ] Non-sterile products [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) [ 1.2.1.17 ] Other non-sterile medicinal productsDrug Substance Intermediates including non-sterile lyophilised powders [ 1.3 ] Biological medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.2 ] Immunological products [ 1.3.1.5 ] Biotechnology products [ 1.3.1.8 ] Other biological medicinal productsBiological intermediates and drug substance for vaccine production [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 1.6 ] Quality control testing [ 1.6.1 ] Microbiological: sterility [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical [ 1.6.4 ] Biological
- Restrictions
- Inspection scope restricted to Biological Vaccine intermediates Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products Train 1; Building B110 plus Train 2 in B110 for Lyophilisation only
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ID · f976e622-16ee-4386-a9d9-9bd3e79dfa01
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