Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 11387 |
|---|---|
| 2: Name of authorisation holder | GUY'S AND ST THOMAS' NHS FOUNDATION TRUST |
| 3: Address(es) of manufacturing site(s) |
GUY'S AND ST THOMAS' NHS FOUNDATION TRUST, PHARMACY PRODUCTION UNIT, GUY'S HOSPITAL, GREAT MAZE POND, LONDON, SE1 9RT, UNITED KINGDOM GUY'S AND ST THOMAS' NHS FOUNDATION TRUST, THE FMT LABORATORY, CENTRE FOR CLINICAL INFECTION AND DIAGNOSTIC RESEARCH, NORTH WING, FLOOR 5, ST THOMAS'S HOSPITAL, WESTMINSTER BRIDGE ROAD, LONDON, SE1 7EH, UNITED KINGDOM CLINICAL PET CENTRE, ST THOMAS HOSPITAL, WESTMINSTER BRIDGE ROAD, LONDON, SE1 7EH, UNITED KINGDOM GUY'S AND ST THOMAS' NHS FOUNDATION TRUST, CLINICAL RESEARCH FACILITY, 15TH FLOOR, TOWER WING, GUY'S HOSPITAL, GREAT MAZE POND, LONDON, SE1 9RT, UNITED KINGDOM RADIOPHARMACY UNIT, RADIOPHARMACY UNIT, NUCLEAR MEDICINE, GUY'S HOSPITAL, GREAT MAZE POND, LONDON, SE1 9RT, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | GUY'S AND ST THOMAS' NHS FOUNDATION TRUST, PHARMACY MANUFACTURING UNIT, 13TH FLOOR, GUY'S TOWER, GUY'S HOSPITAL, GREAT MAZE POND, LONDON, SE1 9RT, UNITED KINGDOM |
| 5: Scope of authorisation and dosage forms | ANNEX 1 and/ or ANNEX 2 |
| 6: Legal Basis of authorisation | |
| 7: Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation | Confidential |
| 8: Authorisation Date | 18/04/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
GUY'S AND ST THOMAS' NHS FOUNDATION TRUST, PHARMACY PRODUCTION UNIT, GUY'S HOSPITAL, GREAT MAZE POND, LONDON, SE1 9RT, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 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 |
| [ 1.1.1.4 ] Small volume liquids |
| [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms) |
| [ 1.1.2.1 ] Large volume liquids |
| [ 1.1.2.2 ] Semi-solids |
| [ 1.1.2.3 ] Small volume liquids |
| [ 1.2 ] Non-sterile investigational medicinal products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.1 ] Capsules, hard shell |
| [ 1.2.1.5 ] Liquids for external use |
| [ 1.2.1.6 ] Liquids for internal use |
| [ 1.2.1.11 ] Semi-solids |
| [ 1.2.1.13 ] Tablets |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
| [ 1.4.2.3 ] Moist heat |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.5 ] Liquids for external use |
| [ 1.5.1.6 ] Liquids for internal use |
| [ 1.5.1.11 ] Semi-solids |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.1.15 ] Other non-sterile medicinal products Solid non-sterile including powders and granules |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
GUY'S AND ST THOMAS' NHS FOUNDATION TRUST, THE FMT LABORATORY, CENTRE FOR CLINICAL INFECTION AND DIAGNOSTIC RESEARCH, NORTH WING, FLOOR 5, ST THOMAS'S HOSPITAL, WESTMINSTER BRIDGE ROAD, LONDON, SE1 7EH, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile investigational medicinal products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.1 ] Capsules, hard shell |
| [ 1.2.1.6 ] Liquids for internal use |
| [ 1.2.1.15 ] Other non-sterile medicinal products Faecal Microbiota for transplantation (FMT) |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.6 ] Human or animal extracted products |
| [ 1.3.1.8 ] Other biological medicinal products Faecal Microbiota for transplantation (FMT) |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.6 ] Human or animal extracted products |
| [ 1.3.2.8 ] Other biological medicinal products Faecal Microbiota for transplantation (FMT) |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.6 ] Liquids for internal use |
| [ 1.5.1.15 ] Other non-sterile medicinal products Faecal Microbiota for transplantation (FMT) |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
CLINICAL PET CENTRE, ST THOMAS HOSPITAL, WESTMINSTER BRIDGE ROAD, LONDON, SE1 7EH, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 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 |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
GUY'S AND ST THOMAS' NHS FOUNDATION TRUST, CLINICAL RESEARCH FACILITY, 15TH FLOOR, TOWER WING, GUY'S HOSPITAL, GREAT MAZE POND, LONDON, SE1 9RT, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1)IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 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 |
| [ 1.1.1.4 ] Small volume liquids |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.3 ] Cell therapy products Special Requirements ATMPs |
| [ 1.3.1.4 ] Gene therapy products Special Requirements ATMPs |
| [ 1.3.1.5 ] Biotechnology products |
| [ 1.3.1.8 ] Other biological medicinal products Autologous or allogeneic cell therapies for intravenous or solid tissue |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
| [ 1.6 ] Quality control testing |
| [ 1.6.1 ] Microbiological: sterility |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.2 ] Batch certification of imported medicinal products |
| [ 2.2.3 ] Biological medicinal products |
| [ 2.2.3.3 ] Cell therapy products |
| [ 2.2.3.4 ] Gene therapy products |
RADIOPHARMACY UNIT, RADIOPHARMACY UNIT, NUCLEAR MEDICINE, GUY'S HOSPITAL, GREAT MAZE POND, LONDON, SE1 9RT, UNITED KINGDOM
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 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 |
| [ 1.1.1.6 ] Other aseptically prepared products Radiopharmaceuticals |
| [ 1.1.3 ] Batch certification |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.8 ] Other biological medicinal products Radiopharmaceuticals; Nano-antibodies |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.15 ] Other non-sterile medicinal products Solid non-sterile including powders and granules |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |