Uk Mhra Gmp
SARTORIUS STEDIM BIOOUTSOURCE LIMITEDSARTORIUS STEDIM BIOOUTSOURCE LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 32917 Insp GMP/IMP 32917/16466470-0004[I]
Record Details
This Uk Mhra Gmp record concerns SARTORIUS STEDIM BIOOUTSOURCE LIMITED, with an inspection on December 19, 2024, issued by the MHRA, covering biologics.
- Compliance status
- GMPC
- Certificate type
- GMP/IMP
- Inspection date
- December 19, 2024
- Issued
- December 19, 2024
- MIA number
- UK MIA(IMP) 32917
- Site address
- 2ND FLOOR, BIOCITY SCOTLAND, BO'NESS ROAD, MOTHERWELL, ML1 5UH, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Investigational Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.3 ] Biological investigational medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.8 ] Other biological medicinal productsMammalian Cell banks - MCB and WCB [ 1.3.2 ] Batch certification [ 1.3.2.8 ] Other biological medicinal productsMammalian Cell banks - MCB and WCB [ 1.6 ] Quality control testing [ 1.6.1 ] Microbiological: sterility [ 1.6.2 ] Microbiological: non-sterility 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
- 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 · e4823b3b-588e-4f36-8d73-0ba72fe868d9
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