Uk Mhra Gmp
NORGINE LIMITEDNORGINE LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 322 Insp IMP 322/14798-0031[I]
Record Details
This Uk Mhra Gmp record concerns NORGINE LIMITED, with an inspection on February 26, 2025, issued by the MHRA, covering drugs.
- Company
- NORGINE LIMITED
- Compliance status
- GMPC
- Certificate type
- IMP
- Inspection date
- February 26, 2025
- Issued
- February 26, 2025
- MIA number
- UK MIA(IMP) 322
- Site address
- NEW ROAD, TIR-Y-BERTH, HENGOED, CF82 8SJ, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Investigational Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Investigational Medicinal Products [ 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) [ 1.2.1.1 ] Capsules, hard shell [ 1.2.1.5 ] Liquids for external use [ 1.2.1.6 ] Liquids for internal use [ 1.2.1.8 ] Other solid dosage forms [ 1.2.1.12 ] Suppositories [ 1.5 ] Packaging [ 1.5.1 ] Primary packaging [ 1.5.1.1 ] Capsules, hard shell [ 1.5.1.2 ] Capsules, soft shell [ 1.5.1.5 ] Liquids for external use [ 1.5.1.6 ] Liquids for internal use [ 1.5.1.8 ] Other solid dosage forms [ 1.5.1.11 ] Semi-solids [ 1.5.1.13 ] Tablets [ 1.5.1.17 ] Other non-sterile medicinal productsPessaries, Powders [ 1.5.2 ] Secondary packaging [ 1.6 ] Quality control testing [ 1.6.3 ] Chemical/Physical 2. IMPORTATION OF MEDICINAL PRODUCTS [ 2.1 ] Quality control testing of imported medicinal products [ 2.1.3 ] Chemical/Physical [ 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 [ 2.3 ] Other Importation Activities [ 2.3.4 ] OtherImportation of QP-certified IMPs from a country on the approved country for import list
- Restrictions
- This certificate is issued based on a desk-based assessment of GMP compliance information provided by the manufacturer. This certificate should be used in combination with the relevant authorisation/registration. A risk-based site inspection programme remains in force.
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ID · 5612dd9f-b210-4e7b-9549-563768fb8ed1
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