Uk Mhra Gmp
PFIZER INCORPORATEDPFIZER INCORPORATED – UK MHRA GMP Certificate UK GMP 6268 Insp GMP 6579/604899-0010 [V]
Record Details
This Uk Mhra Gmp record concerns PFIZER INCORPORATED, with an inspection on May 16, 2016, issued by the MHRA, covering veterinary.
- Company
- PFIZER INCORPORATED
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- May 16, 2016
- Issued
- December 7, 2016
- MIA number
- UK GMP 6268
- Site address
- 7000 PORTAGE ROAD, KALAMAZOO, 49001, UNITED STATES
- Country
- UNITED STATES
- Products
- Veterinary 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) [ 1.1.2.2 ] Semi-solids [ 1.1.2.3 ] Small volume liquids [ 1.2 ] Non-sterile products [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) [ 1.2.1.5 ] Liquids for external use [ 1.2.1.6 ] Liquids for internal use [ 1.2.1.11 ] Semi-solids [ 1.2.1.12 ] Suppositories [ 1.2.1.17 ] Other non-sterile medicinal productsSuspensions, Nasal Sprays sprays (pump liquid type not metered dose inhalers which are pressurised) [ 1.3 ] Biological medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.2 ] Immunological products [ 1.3.1.8 ] Other biological medicinal productsImmunoglobulin derived from horse serum both as a bulk API lyophilised and is then making the finish [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 1.4.2.2 ] Dry heat [ 1.4.2.3 ] Moist heat [ 1.4.3 ] OtherSuper critical fluid carbon dioxide sterilisation [ 1.5 ] Packaging [ 1.5.2 ] Secondary packaging [ 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 Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products B41 - Note The Pfizer Kalamazoo legal entity name is: Pharmacia and Upjohn Company, LLC Physical, chemical, biological, microbiology - sterile and non sterile ATGAM Biological pre-approval inspection
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ID · a246856c-40c8-4a88-9f3e-d689d1994490
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