Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 32917 |
|---|---|
| 2: Name of authorisation holder | SARTORIUS STEDIM BIOOUTSOURCE LIMITED |
| 3: Address(es) of manufacturing site(s) |
SARTORIUS STEDIM BIOOUTSOURCE LIMITED, 2ND FLOOR, BIOCITY SCOTLAND, BO'NESS ROAD, MOTHERWELL, ML1 5UH, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | SARTORIUS STEDIM BIOOUTSOURCE LIMITED, 1 TECHNOLOGY TERRACE, TODD CAMPUS, WEST OF SCOTLAND SCIENCE PARK, GLASGOW, G20 0XA, 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 | 17/04/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
SARTORIUS STEDIM BIOOUTSOURCE LIMITED, 2ND FLOOR, BIOCITY SCOTLAND, BO'NESS ROAD, MOTHERWELL, ML1 5UH, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.8 ] Other biological medicinal products Mammalian Cell banks - MCB and WCB |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.8 ] Other biological medicinal products Mammalian Cell banks - MCB and WCB |
| [ 1.6 ] Quality control testing |
| [ 1.6.1 ] Microbiological: sterility |
| [ 1.6.2 ] Microbiological: non-sterility |