Uk Mhra Gmp
FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITEDFUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 18480 Insp GMP/IMP 18480/10934-0018[I]
Record Details
This Uk Mhra Gmp record concerns FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED, with an inspection on March 18, 2025, issued by the MHRA, covering biologics.
- Compliance status
- GMPC
- Certificate type
- GMP/IMP
- Inspection date
- March 18, 2025
- Issued
- March 18, 2025
- MIA number
- UK MIA(IMP) 18480
- Site address
- BELASIS AVENUE, BILLINGHAM, TS23 1LH, 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 [ 1.3.1.2 ] Immunological products [ 1.3.1.5 ] Biotechnology products [ 1.3.1.8 ] Other biological medicinal productsManufacturing of recombinant protein and nucleotide intermediates and active pharmaceutical ingredients, cell bank manufacturing, storage of (non-pathogenic) baculovirus seed bank for insect cell culture [ 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 · 5d5dcd6a-0da4-41ef-9ea6-f5a6d54617fc
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