Uk Mhra Gmp
GLAXO OPERATIONS UK LTD (WARE) T\A GLAXO WELLCOME OPERATIONSGLAXO OPERATIONS UK LTD (WARE) T\A GLAXO WELLCOME OPERATIONS – UK MHRA GMP Certificate UK API 4 Insp GMP/GDP 4/15159-0034
Record Details
This Uk Mhra Gmp record concerns GLAXO OPERATIONS UK LTD (WARE) T\A GLAXO WELLCOME OPERATIONS, with an inspection on December 3, 2024, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP/GDP
- Inspection date
- December 3, 2024
- Issued
- January 28, 2025
- MIA number
- UK API 4
- Site address
- PRIORY STREET, WARE, SG12 0DJ, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- [4000014056] DOLUTEGRAVIR SODIUM [2000014516] FLUTICASONE FUROATE [4000013535] VILANTEROL TRIFENATATE [2000008220] FLUTICASONE PROPIONATE [4000014045] UMECLIDINIUM BROMIDE [2000008392] SALMETEROL XINAFOATE [2000017021] CABOTEGRAVIR SODIUM Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES DOLUTEGRAVIR SODIUM 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Micronisation for GW Manufacturing and Shanghai Desano Chemical 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) FLUTICASONE FUROATE 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Micronisation 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) VILANTEROL TRIFENATATE 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Micronisation 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) FLUTICASONE PROPIONATE 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Micronisation 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) UMECLIDINIUM BROMIDE 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Micronisation 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) SALMETEROL XINAFOATE 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Micronisation 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) CABOTEGRAVIR SODIUM 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Micronisation 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products The GMP certificate is restricted to specifically reflect the buildings that have been inspected by the MHRA for the manufacture and testing of medicinal products: A, M, N10, N12, P, S Building (S1 and S2), U2, U3, V, V1, Z1.
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