Uk Mhra Gmp
NORTON HEALTHCARE LIMITED T\A IVAX PHARMACEUTICALS UKNORTON HEALTHCARE LIMITED T\A IVAX PHARMACEUTICALS UK – UK MHRA GMP Certificate UK MIA(IMP) 530 Insp GMP/IMP 20864/14004-0036[I]
Record Details
This Uk Mhra Gmp record concerns NORTON HEALTHCARE LIMITED T\A IVAX PHARMACEUTICALS UK, with an inspection on December 9, 2024, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP/IMP
- Inspection date
- December 9, 2024
- Issued
- December 9, 2024
- MIA number
- UK MIA(IMP) 530
- Site address
- ASTON LANE NORTH, WHITEHOUSE VALE INDUSTRIAL ESTATE, RUNCORN, WA7 3FA, 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) [ 1.1.1.4 ] Small volume liquids [ 1.1.1.6 ] Other aseptically prepared productsSuspensions and Emulsions [ 1.1.3 ] Batch certification [ 1.3 ] Biological investigational medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.8 ] Other biological medicinal productsMonoclonal Antibodies [ 1.3.2 ] Batch certification [ 1.3.2.8 ] Other biological medicinal productsMonoclonal Antibodies [ 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 [ 2.1.4 ] Biological [ 2.3 ] Other Importation Activities [ 2.3.2 ] Importation of Intermediate which undergoes further processing
- 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 · 60b79bd5-a2de-4af5-a468-73adae3427fe
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