Uk Mhra Gmp
GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONSGLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS – UK MHRA GMP Certificate UK MIA 4 Insp GMP 4/3848-0050[H]
Record Details
This Uk Mhra Gmp record concerns GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS, with an inspection on August 22, 2023, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- August 22, 2023
- Issued
- May 20, 2026
- MIA number
- UK MIA 4
- Site address
- HARMIRE ROAD, BARNARD CASTLE, DL12 8DT, UNITED KINGDOM
- Country
- UNITED KINGDOM
- 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 [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms) [ 1.1.2.3 ] Small volume liquids [ 1.1.2.5 ] Other terminally sterilised prepared productsManufacture of parametrically released products where authorised by the individual Marketing Authorisation [ 1.1.3 ] Batch certification [ 1.2 ] Non-sterile products [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) [ 1.2.1.6 ] Liquids for internal use [ 1.2.1.11 ] Semi-solids [ 1.2.1.17 ] Other non-sterile medicinal productsLicensable Medical Devices [ 1.2.2 ] Batch certification [ 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 productsSteroids, Antibacterial Agents, Antifungal Agents [ 1.3.2 ] Batch certification [ 1.3.2.2 ] Immunological products [ 1.3.2.5 ] Biotechnology products [ 1.3.2.8 ] Other biological medicinal productsSteroids, Antibacterial Agents, Antifungal Agents [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 1.4.2.3 ] Moist heat [ 1.5 ] Packaging [ 1.5.1 ] Primary packaging [ 1.5.1.6 ] Liquids for internal use [ 1.5.1.11 ] Semi-solids [ 1.5.1.17 ] Other non-sterile medicinal productsLicensable Medical Devices [ 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 2. IMPORTATION OF MEDICINAL PRODUCTS [ 2.3 ] Other Importation Activities [ 2.3.2 ] Importation of Intermediate which undergoes further processing
- Restrictions
- MIA(IMP) packaging operations restricted to open label, non-randomised activities. Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products This GMP certificate is applicable to sterile and non sterile manufacturing activities conducted in C block, storage activities and packaging material testing in J block, and Quality Control and laboratory operations in E and L block. It includes sterile manufacturing activities in Q block.
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