Uk Mhra Gmp
AB BIOTECHNOLOGY LIMITEDAB BIOTECHNOLOGY LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 42415 Insp GMP/IMP 42415/87413-0011[I]
Record Details
This Uk Mhra Gmp record concerns AB BIOTECHNOLOGY LIMITED, with an inspection on December 11, 2024, issued by the MHRA, covering biologics.
- Company
- AB BIOTECHNOLOGY LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP/IMP
- Inspection date
- December 11, 2024
- Issued
- December 11, 2024
- MIA number
- UK MIA(IMP) 42415
- Site address
- PENTLANDS SCIENCE PARK, BUSH LOAN, PENICUIK, EH26 0PZ, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Investigational Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.3 ] Biological investigational medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.8 ] Other biological medicinal productsDrug Substance - Manufacture of biological actives (purified viral inactivated, rabbit polyclonal antisera) for use in oral medicinal products [ 1.3.2 ] Batch certification [ 1.3.2.8 ] Other biological medicinal productsDrug Substance - Manufacture of biological actives (purified viral inactivated, rabbit polyclonal antisera) for use in oral medicinal products [ 1.4 ] Other products or manufacturing activity [ 1.4.1 ] Manufacture of: [ 1.4.1.3 ] OtherDrug Substance - Manufacture of biological actives (purified viral inactivated, rabbit polyclonal antisera) for use in oral medicinal products [ 1.6 ] Quality control testing [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical [ 1.6.4 ] Biological
- Restrictions
- This certificate is issued based on a desk-based assessment of GMP compliance information provided by the manufacturer. This certificate should be used in combination with the relevant authorisation/registration. A risk-based site inspection programme remains in force.
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ID · a58ced65-80d9-4547-9194-33d721f3ae5d
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