Uk Mhra Gmp
PATHEON UK LIMITEDPATHEON UK LIMITED – UK MHRA GMP Certificate UK MIA 17857 Insp GMP/IMP 17857/10036-0034[H]
Record Details
This Uk Mhra Gmp record concerns PATHEON UK LIMITED, with an inspection on July 29, 2024, issued by the MHRA, covering drugs.
- Company
- PATHEON UK LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP/IMP
- Inspection date
- July 29, 2024
- Issued
- April 7, 2025
- MIA number
- UK MIA 17857
- Site address
- KINGFISHER DRIVE, COVINGHAM, SWINDON, SN3 5BZ, 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) [ 1.1.1.2 ] Lyophilisates [ 1.1.1.4 ] Small volume liquids [ 1.1.1.6 ] Other aseptically prepared productsPowder, Cytostatics [ 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 productsTerminally sterilised microspheres of TCA and PLGA presented in vial [ 1.1.3 ] Batch certification [ 1.3 ] Biological medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.2 ] Immunological products [ 1.3.1.4 ] Gene therapy products [ 1.3.1.5 ] Biotechnology products [ 1.3.1.6 ] Human or animal extracted products [ 1.3.2 ] Batch certification [ 1.3.2.2 ] Immunological 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 [ 1.5.2 ] 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 [ 2.1 ] Quality control testing of imported medicinal products [ 2.1.1 ] Microbiological: sterility [ 2.1.2 ] Microbiological: non-sterility [ 2.1.3 ] Chemical/Physical [ 2.1.4 ] Biological [ 2.2 ] Batch certification of imported medicinal products [ 2.2.1 ] Sterile Products [ 2.2.1.1 ] Aseptically prepared [ 2.2.1.2 ] Terminally sterilised [ 2.2.2 ] Non-sterile products [ 2.2.3 ] Biological medicinal products [ 2.2.3.2 ] Immunological products [ 2.2.3.4 ] Gene therapy products [ 2.2.3.5 ] Biotechnology products [ 2.2.3.6 ] Human or animal extracted products
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