Uk Mhra Gmp
ROCHE PRODUCTS LIMITEDROCHE PRODUCTS LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 31 Insp GMP/IMP 14878/86087-0022[I]
Record Details
This Uk Mhra Gmp record concerns ROCHE PRODUCTS LIMITED, with an inspection on January 15, 2025, issued by the MHRA, covering drugs.
- Company
- ROCHE PRODUCTS LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP/IMP
- Inspection date
- January 15, 2025
- Issued
- January 15, 2025
- MIA number
- UK MIA(IMP) 31
- Site address
- 6 FALCON WAY, SHIRE PARK, WELWYN GARDEN CITY, AL7 1TW, 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 [ 1.2.2 ] Batch certification [ 1.3 ] Biological investigational medicinal products [ 1.3.2 ] Batch certification [ 1.3.2.2 ] Immunological products [ 1.3.2.5 ] Biotechnology products [ 1.3.2.6 ] Human or animal extracted products [ 1.4 ] Other products or manufacturing activity [ 1.4.1 ] Manufacture of: [ 1.4.1.3 ] OtherBatch Certification of non-sterile products/Importation of QP certified IMPs from a country on the approved country for import list 2. IMPORTATION OF MEDICINAL PRODUCTS [ 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 [ 2.2.3.1 ] Blood products [ 2.2.3.2 ] Immunological products [ 2.2.3.3 ] Cell therapy products [ 2.2.3.4 ] Gene therapy products [ 2.2.3.5 ] Biotechnology products [ 2.2.3.6 ] Human or animal extracted products [ 2.3 ] Other Importation Activities [ 2.3.4 ] OtherBatch Certification of non-sterile products/Importation 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 · 37f16e1c-52cb-4ad6-af46-f760100ff570
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