Uk Mhra Gmp
GLAXOSMITHKLINEGLAXOSMITHKLINE – UK MHRA GMP Certificate UK API 4 Insp GMP 4/117769-0021 [H]
Record Details
This Uk Mhra Gmp record concerns GLAXOSMITHKLINE, with an inspection on November 10, 2020, issued by the MHRA, covering drugs.
- Company
- GLAXOSMITHKLINE
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- November 10, 2020
- Issued
- November 27, 2020
- MIA number
- UK API 4
- Site address
- COBDEN STREET, MONTROSE, DD10 8EA, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- [1000000992] ZANAMIVIR [1000007791] DUTASTERIDE [2000008220] FLUTICASONE PROPIONATE [4000013535] VILANTEROL TRIFENATATE [1000008398] ALUMINIUM PHOSPHATE [2000008014] CLOBETASOL PROPIONATE [2000008358] BETAMETHASONE VALERATE [2000014516] FLUTICASONE FUROATE [2000008013] CLOBETASONE BUTYRATE [1000007375] LACIDIPINE [2000007742] SALBUTAMOL SULPHATE [4000003016] ABACAVIR SULFATE Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES ZANAMIVIR 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.2 Manufacture Of Crude Active Substance 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Rehumidification, Blending, Sieving 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) DUTASTERIDE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.2 Manufacture Of Crude Active Substance 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing FLUTICASONE PROPIONATE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.2 Manufacture Of Crude Active Substance 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, Sieving. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing VILANTEROL TRIFENATATE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.2 Manufacture Of Crude Active Substance 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing ALUMINIUM PHOSPHATE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.4 Other Inorganic sterile salt suspension 3.4 Manufacture of sterile active substance 3.4.2 Terminally sterilised 3.5 General Finishing Steps 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.3 Microbiological testing (including sterility testing) CLOBETASOL PROPIONATE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.2 Manufacture Of Crude Active Substance 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, Sieving. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing BETAMETHASONE VALERATE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.2 Manufacture Of Crude Active Substance 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, micronisation. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing FLUTICASONE FUROATE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.2 Manufacture Of Crude Active Substance 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing CLOBETASONE BUTYRATE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.2 Manufacture Of Crude Active Substance 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, micronisation. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing LACIDIPINE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.2 Manufacture Of Crude Active Substance 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, Sieving. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing SALBUTAMOL SULPHATE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Sulphate salt formation and crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, Sieving. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing ABACAVIR SULFATE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Crystallisation and salt formation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, Seiving. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing
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