Uk Mhra Gmp
CHARLES RIVER DISCOVERY RESEARCH SERVICES UK LIMITEDCHARLES RIVER DISCOVERY RESEARCH SERVICES UK LIMITED – UK MHRA GMP Certificate UK MIA 57623 Insp GMP 57623/36548-0016[H]
Record Details
This Uk Mhra Gmp record concerns CHARLES RIVER DISCOVERY RESEARCH SERVICES UK LIMITED, with an inspection on December 16, 2020, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- December 16, 2020
- Issued
- May 22, 2024
- MIA number
- UK MIA 57623
- Site address
- STEPHENSON BUILDING, THE SCIENCE PARK, KEELE, NEWCASTLE, ST5 5SP, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Products [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) [ 1.1.1.4 ] Small volume liquids Special Requirements Pathogenic Organisms (Biosafety Level 3 or 4) [ 1.2 ] Non-sterile products [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) [ 1.2.1.6 ] Liquids for internal use Special Requirements Live Cells [ 1.2.1.17 ] Other non-sterile medicinal productsManufacture of low bioburden bulk drug substance solutions Special Requirements Live Cells [ 1.3 ] Biological medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.2 ] Immunological products Special Requirements Live Cells [ 1.3.1.4 ] Gene therapy products Special Requirements Live Cells [ 1.3.1.5 ] Biotechnology products Special Requirements Live Cells [ 1.3.1.8 ] Other biological medicinal productsAntibodies,Antibody conjugates, Live microbial products, Therapeutic Virus, Plant extracted materials Special Requirements Live Cells [ 1.3.2 ] Batch certification [ 1.3.2.2 ] Immunological products Special Requirements Live Cells [ 1.3.2.4 ] Gene therapy products Special Requirements Live Cells [ 1.3.2.5 ] Biotechnology products Special Requirements Live Cells [ 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 [ 1.6 ] Quality control testing [ 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 [ 2.1.2 ] Microbiological: non-sterility [ 2.1.3 ] Chemical/Physical [ 2.1.4 ] Biological [ 2.3 ] Other Importation Activities [ 2.3.1 ] Site of Physical Importation [ 2.3.2 ] Importation of Intermediate which undergoes further processing
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ID · c93bad47-a5ba-44ff-a56a-dcb20e95ee61
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