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(IMP) 4 Insp GMP/IMP 4/3848-0039[I]
Record Details
This Uk Mhra Gmp record concerns GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS, with an inspection on June 14, 2022, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP/IMP
- Inspection date
- June 14, 2022
- Issued
- December 20, 2022
- MIA number
- UK MIA(IMP) 4
- Site address
- HARMIRE ROAD, BARNARD CASTLE, DL12 8DT, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Investigational Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Investigational Medicinal Products [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) [ 1.1.1.1 ] Large volume liquids [ 1.1.1.4 ] Small volume liquids [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms) [ 1.1.2.1 ] Large volume liquids [ 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 investigational medicinal products [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) [ 1.2.1.11 ] Semi-solids [ 1.2.2 ] Batch certification [ 1.3 ] Biological investigational medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.5 ] Biotechnology products [ 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 [ 1.5.1.11 ] Semi-solids [ 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 2. IMPORTATION OF MEDICINAL PRODUCTS [ 2.1 ] Quality control testing of imported medicinal products [ 2.1.3 ] Chemical/Physical
- 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.
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