Uk Mhra Gmp
QUOTIENT SCIENCES LIMITEDQUOTIENT SCIENCES LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 35718 Insp IMP 35718/8697-0030[I]
Record Details
This Uk Mhra Gmp record concerns QUOTIENT SCIENCES LIMITED, with an inspection on April 1, 2026, issued by the MHRA, covering drugs.
- Company
- QUOTIENT SCIENCES LIMITED
- Compliance status
- GMPC
- Certificate type
- IMP
- Inspection date
- April 1, 2026
- Issued
- April 10, 2026
- MIA number
- UK MIA(IMP) 35718
- Site address
- QUOTIENT SCIENCES LIMITED, TRENT HOUSE/SHERWOOD HOUSE/LIME HOUSE, MERE WAY, RUDDINGTON FIELDS, RUDDINGTON, NOTTINGHAM, NG11 6JS, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Investigational Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Investigational Medicinal Products [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) [ 1.1.1.6 ] Other aseptically prepared productsClinical labelling and/or randomisation & blinding and batch certification of sterile IMPs manufactured at other authorised manufacturing sites [ 1.1.3 ] Batch certification [ 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 [ 1.2.1.8 ] Other solid dosage forms [ 1.2.1.9 ] Pressurised preparations [ 1.2.1.11 ] Semi-solids [ 1.2.1.12 ] Suppositories [ 1.2.1.13 ] Tablets [ 1.2.1.17 ] Other non-sterile medicinal productsAny products listed in 1.2 may be radiolabelled and contain antibiotics, cytotoxics, biotechnology, human or animal derived products. [ 1.2.2 ] Batch certification [ 1.3 ] Biological investigational medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.5 ] Biotechnology products [ 1.3.1.8 ] Other biological medicinal productsRadiolabelling and/or aseptic assembly of pre-formulated biologicals. Any of the products listed in section 1.3 may contain Antibiotics, Cytototoxics, Biotechnology and Human or Animal derived products. [ 1.3.2 ] Batch certification [ 1.3.2.5 ] Biotechnology products [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 1.5 ] Packaging [ 1.5.1 ] Primary packaging [ 1.5.1.1 ] Capsules, hard shell [ 1.5.1.5 ] Liquids for external use [ 1.5.1.6 ] Liquids for internal use [ 1.5.1.8 ] Other solid dosage forms [ 1.5.1.9 ] Pressurised preparations [ 1.5.1.11 ] Semi-solids [ 1.5.1.12 ] Suppositories [ 1.5.1.13 ] Tablets [ 1.5.2 ] Secondary packaging [ 1.6 ] Quality control testing [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical 2. IMPORTATION OF MEDICINAL PRODUCTS [ 2.1 ] Quality control testing of imported medicinal products [ 2.1.2 ] Microbiological: non-sterility [ 2.1.3 ] Chemical/Physical [ 2.2 ] Batch certification of imported medicinal products [ 2.2.1 ] Sterile Products [ 2.2.1.1 ] Aseptically prepared [ 2.2.2 ] Non-sterile products [ 2.2.3 ] Biological medicinal products [ 2.2.3.8 ] Other biological medicinal productsRadiolabelling and/or aseptic assembly of pre-formulated biologicals. Any of the products listed in section 1.3 may contain Antibiotics, Cytototoxics, Biotechnology and Human or Animal derived products. [ 2.3 ] Other Importation Activities [ 2.3.1 ] Site of Physical Importation [ 2.3.2 ] Importation of Intermediate which undergoes further processing [ 2.3.4 ] OtherImportation of QP-certified IMPs from a country on the approved country for import list
- Restrictions
- GMP manufacturing activities performed in Trent House; QC activities performed in Lime House. 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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