Uk Mhra Gmp
SIMBEC RESEARCH LIMITEDSIMBEC RESEARCH LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 4757 Insp IMP 4757/15685-0040[I]
Record Details
This Uk Mhra Gmp record concerns SIMBEC RESEARCH LIMITED, with an inspection on November 3, 2022, issued by the MHRA, covering drugs.
- Company
- SIMBEC RESEARCH LIMITED
- Compliance status
- GMPC
- Certificate type
- IMP
- Inspection date
- November 3, 2022
- Issued
- November 21, 2022
- MIA number
- UK MIA(IMP) 4757
- Site address
- SIMBEC HOUSE, MERTHYR TYDFIL INDUSTRIAL PARK, MERTHYR TYDFIL, CF48 4DR, 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) [ 1.1.1.1 ] Large volume liquids [ 1.1.1.4 ] Small volume liquids [ 1.1.1.5 ] Solids and implants [ 1.1.1.6 ] Other aseptically prepared productsRadiopharmaceuticals small and large volume liquids.Antibodies/other therapeutic proteins.Non live protein based vaccine [ 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 [ 1.2.1.9 ] Pressurised preparations [ 1.2.1.17 ] Other non-sterile medicinal productsSolutions for inhalation/nebulisation, Radiopharmaceuticals (solids, oral solutions, solutions for inhalation/nebulisation). Dry powder for nasal inhalation. Pressurised preparations, specifically radiolabelled products, Oral Powders [ 1.3 ] Biological investigational medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.8 ] Other biological medicinal productsPackaging of dry powder nasal sprays including hGH, Dilution of oral liquid vaccines containing genetically modified live bacteria. [ 1.4 ] Other products or manufacturing activity [ 1.4.1 ] Manufacture of: [ 1.4.1.2 ] Homeopathic products [ 1.5 ] Packaging [ 1.5.1 ] Primary packaging [ 1.5.1.1 ] Capsules, hard shell [ 1.5.1.2 ] Capsules, soft shell [ 1.5.1.3 ] Chewing gums [ 1.5.1.4 ] Impregnated matrices [ 1.5.1.5 ] Liquids for external use [ 1.5.1.6 ] Liquids for internal use [ 1.5.1.12 ] Suppositories [ 1.5.1.13 ] Tablets [ 1.5.1.14 ] Transdermal patches [ 1.5.1.17 ] Other non-sterile medicinal productsSolutions for inhalation/nebulisation, Radiopharmaceuticals (solids, oral solutions, solutions for inhalation/nebulisation). Dry powder for nasal inhalation. Pressurised preparations, specifically radiolabelled products, Oral Powders [ 1.5.2 ] Secondary packaging [ 1.6 ] Quality control testing [ 1.6.3 ] Chemical/Physical 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 [ 2.2.3.5 ] Biotechnology 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 ] OtherRadiopharmaceuticals/radionuclide generators/ Importation of QP certified IMPs from a country on the approved country for import list
- Restrictions
- This was a focused remote inspection following a variation to add oversight process for IMP from listed countries. Scope of QC testing limited to HPLC analysis. Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products Scope of QC testing limited to HPLC analysis.
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ID · 33034495-0878-4555-9cdc-19d1b33bb2a7
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