Uk Mhra Gmp
CP PHARMACEUTICALS LIMITEDCP PHARMACEUTICALS LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 4543 Insp GMP/IMP 4543/15498-0055[I]
Record Details
This Uk Mhra Gmp record concerns CP PHARMACEUTICALS LIMITED, with an inspection on September 12, 2022, issued by the MHRA, covering drugs.
- Company
- CP PHARMACEUTICALS LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP/IMP
- Inspection date
- September 12, 2022
- Issued
- February 24, 2023
- MIA number
- UK MIA(IMP) 4543
- Site address
- ASH ROAD NORTH, WREXHAM, LL13 9UF, 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) [ 1.1.1.2 ] Lyophilisates [ 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 [ 1.1.3 ] Batch certification [ 1.2 ] Non-sterile investigational medicinal products [ 1.2.2 ] Batch certification [ 1.3 ] Biological investigational medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.5 ] Biotechnology products [ 1.3.1.6 ] Human or animal extracted products [ 1.3.1.8 ] Other biological medicinal productsManufacture of products based on botanical extracts and hormones. [ 1.3.2 ] Batch certification [ 1.3.2.5 ] Biotechnology products [ 1.3.2.6 ] Human or animal extracted products [ 1.3.2.8 ] Other biological medicinal productsManufacture of products based on botanical extracts and hormones. [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 1.4.2.2 ] Dry heat [ 1.4.2.3 ] Moist heat [ 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 [ 2.2.3.5 ] Biotechnology products [ 2.2.3.6 ] Human or animal extracted products [ 2.3 ] Other Importation Activities [ 2.3.1 ] Site of Physical Importation
- Restrictions
- MIA(IMP) packaging operations restricted to open label, non-randomised activities
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ID · a5397dba-3f92-4366-8614-df84bfb1cce5
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