Uk Mhra Gmp
QUOTIENT SCIENCES LIMITEDQUOTIENT SCIENCES LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 35718 Insp IMP 35718/876362-0015[I]
Record Details
This Uk Mhra Gmp record concerns QUOTIENT SCIENCES LIMITED, with an inspection on February 4, 2022, issued by the MHRA, covering drugs.
- Company
- QUOTIENT SCIENCES LIMITED
- Compliance status
- GMPC
- Certificate type
- IMP
- Inspection date
- February 4, 2022
- Issued
- February 14, 2022
- MIA number
- UK MIA(IMP) 35718
- Site address
- 5 BOULTON ROAD, READING, RG2 0NH, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Investigational Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 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 productsBlister/Multidose Resovoir Dry Powder Inhaler,DPI/PMDI [ 1.2.2 ] Batch certification [ 1.3 ] Biological investigational medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.5 ] Biotechnology products [ 1.4 ] Other products or manufacturing activity [ 1.4.1 ] Manufacture of: [ 1.4.1.1 ] Herbal products [ 1.4.1.3 ] OtherTraditional Herbal Medicines/Importation of QP-certified IMPs from a country on the approved countr [ 1.5 ] Packaging [ 1.5.1 ] Primary packaging [ 1.5.1.1 ] Capsules, hard shell [ 1.5.1.2 ] Capsules, soft shell [ 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 [ 1.5.1.14 ] Transdermal patches [ 1.5.2 ] Secondary packaging [ 1.6 ] Quality control testing [ 1.6.3 ] Chemical/Physical [ 1.6.4 ] Biological 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 [ 2.3 ] Other Importation Activities [ 2.3.1 ] Site of Physical Importation [ 2.3.4 ] OtherTraditional Herbal Medicines/Importation of QP-certified IMPs from a country on the approved countr
- Restrictions
- This was a focused remote inspection following a variation to add import oversight for IMP from listed countries.
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ID · 7a4aeaa2-a3c6-43ad-a28d-c14a0770fdb3
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