Uk Mhra Gmp
RAYNE CELL THERAPY SUITE (RCTS)RAYNE CELL THERAPY SUITE (RCTS) – UK MHRA GMP Certificate UK MIA(IMP) 14523 Insp GMP/IMP 14523/23497-0006[I]
Record Details
This Uk Mhra Gmp record concerns RAYNE CELL THERAPY SUITE (RCTS), with an inspection on July 13, 2021, issued by the MHRA, covering biologics.
- Compliance status
- GMPC
- Certificate type
- GMP/IMP
- Inspection date
- July 13, 2021
- Issued
- September 20, 2021
- MIA number
- UK MIA(IMP) 14523
- Site address
- THE RAYNE INSTITUTE, KING'S COLLEGE HOSPITAL & KING'S COLLEGE LONDON, DEPARTMENT OF HAEMATOLOGICAL AND EXPERIMENTAL MEDICINE, THE RAYNE INSTITUTE, 123 COLDHARBOUR LANE, LONDON, SE5 9NU, 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 [ 1.1.3 ] Batch certification [ 1.3 ] Biological investigational medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.1 ] Blood products [ 1.3.1.2 ] Immunological products [ 1.3.1.3 ] Cell therapy products [ 1.3.1.4 ] Gene therapy products [ 1.3.1.5 ] Biotechnology products [ 1.3.1.6 ] Human or animal extracted products [ 1.3.2 ] Batch certification [ 1.3.2.1 ] Blood products [ 1.3.2.2 ] Immunological products [ 1.3.2.3 ] Cell therapy products [ 1.3.2.4 ] Gene therapy products [ 1.3.2.5 ] Biotechnology products [ 1.3.2.6 ] Human or animal extracted products [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 1.5 ] Packaging [ 1.5.2 ] Secondary packaging [ 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 [ 2.2 ] Batch certification of imported medicinal products [ 2.2.1 ] Sterile Products [ 2.2.1.1 ] Aseptically prepared [ 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 [ 2.2.3.8 ] Other biological medicinal productsTissue Engineered Products [ 2.3 ] Other Importation Activities [ 2.3.2 ] Importation of Intermediate which undergoes further processing [ 2.3.4 ] OtherImportation of Intermediate which undergoes further processing Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products No complex, blinded or randomised packaging activities are undertaken at this site. Biotechnology products. Including cell therapy, immunological, gene therapy, blood products and autologous ATMP treatments.
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