Uk Mhra Gmp
BIOTEC SERVICES INTERNATIONAL LIMITEDBIOTEC SERVICES INTERNATIONAL LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 19819 Insp GMP/GDP/IMP 19819/4680309-0005[I]
Record Details
This Uk Mhra Gmp record concerns BIOTEC SERVICES INTERNATIONAL LIMITED, with an inspection on May 16, 2023, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- May 16, 2023
- Issued
- August 14, 2023
- MIA number
- UK MIA(IMP) 19819
- Site address
- UNITS 2100, 2110, 2120, 2130, 2010, 2430 AND 2500, PHASE 18, CENTRAL PARK, BRIDGEND INDUSTRIAL ESTATE, BRIDGEND, CF31 3TY, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Investigational Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Investigational Medicinal Products [ 1.1.3 ] Batch certification [ 1.2 ] Non-sterile investigational medicinal products [ 1.2.2 ] Batch certification [ 1.3 ] Biological investigational medicinal 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 [ 1.3.2.7 ] Tissue Engineered Products [ 1.5 ] Packaging [ 1.5.2 ] Secondary packaging 2. IMPORTATION OF MEDICINAL PRODUCTS [ 2.2 ] Batch certification of imported medicinal products [ 2.2.1 ] Sterile Products [ 2.2.1.1 ] Aseptically prepared [ 2.2.1.2 ] Terminally sterilised [ 2.2.2 ] Non-sterile products [ 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 [ 2.2.3.7 ] Tissue Engineered Products [ 2.2.3.8 ] Other biological medicinal productsTissue engineered products [ 2.3 ] Other Importation Activities [ 2.3.1 ] Site of Physical Importation [ 2.3.4 ] OtherImportation of QP certified IMPs from a country on the approved country for import list & 2.3.5 Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc) Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products This GMP certificate is applicable to activities conducted in Biotec House, PCI-1, PCI-2, PCI-3 and PCI Returns.
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ID · 83334e30-e0f0-4f3a-aed1-70b0e64c2ed5
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