Uk Mhra Gmp
CELL AND GENE THERAPY CATAPULT MANUFACTURING AND INNOVATION CENTRECELL AND GENE THERAPY CATAPULT MANUFACTURING AND INNOVATION CENTRE – UK MHRA GMP Certificate UK MIA(IMP) 59573 Insp IMP 59573/35110486-0002[I]
Record Details
This Uk Mhra Gmp record concerns CELL AND GENE THERAPY CATAPULT MANUFACTURING AND INNOVATION CENTRE, with an inspection on December 6, 2023, issued by the MHRA, covering biologics.
- Compliance status
- GMPC
- Certificate type
- IMP
- Inspection date
- December 6, 2023
- Issued
- July 9, 2024
- MIA number
- UK MIA(IMP) 59573
- Site address
- 4 WARNER DRIVE, SPRINGWOOD INDUSTRIAL ESTATE, BRAINTREE, CM7 2YW, 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) [ 1.1.1.1 ] Large volume liquids Special Requirements Live Cells Advanced Therapy Medicinal Products [ 1.1.1.4 ] Small volume liquids Special Requirements Live Cells Advanced Therapy Medicinal Products [ 1.1.1.6 ] Other aseptically prepared productsCell and viral vector based Advanced Therapeutic Medicinal Products Special Requirements Live Cells Advanced Therapy Medicinal Products [ 1.1.3 ] Batch certification [ 1.3 ] Biological investigational medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.3 ] Cell therapy products Special Requirements Live Cells Advanced Therapy Medicinal Products [ 1.3.1.4 ] Gene therapy products Special Requirements Live Cells Advanced Therapy Medicinal Products [ 1.3.1.5 ] Biotechnology products Special Requirements Live Cells Advanced Therapy Medicinal Products [ 1.3.1.6 ] Human or animal extracted products Special Requirements Live Cells Advanced Therapy Medicinal Products [ 1.3.1.8 ] Other biological medicinal productsViral vectors Special Requirements Live Cells Advanced Therapy Medicinal Products [ 1.3.2 ] Batch certification [ 1.3.2.3 ] Cell therapy products Special Requirements Live Cells Advanced Therapy Medicinal Products [ 1.3.2.4 ] Gene therapy products Special Requirements Live Cells Advanced Therapy Medicinal Products [ 1.3.2.5 ] Biotechnology products Special Requirements Live Cells Advanced Therapy Medicinal Products [ 1.3.2.6 ] Human or animal extracted products Special Requirements Live Cells Advanced Therapy Medicinal Products [ 1.3.2.8 ] Other biological medicinal productsViral vectors Special Requirements Live Cells Advanced Therapy Medicinal Products [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 1.5 ] Packaging [ 1.5.1 ] Primary packaging [ 1.5.1.6 ] Liquids for internal use [ 1.5.1.17 ] Other non-sterile medicinal productsCell based Advanced Therapeutic Medicinal Products [ 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
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