Uk Mhra Gmp
WASDELL MANUFACTURING LIMITEDWASDELL MANUFACTURING LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 43685 Insp GMP/IMP 43685/8071768-0012[I]
Record Details
This Uk Mhra Gmp record concerns WASDELL MANUFACTURING LIMITED, with an inspection on November 27, 2025, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP/IMP
- Inspection date
- November 27, 2025
- Issued
- December 22, 2025
- MIA number
- UK MIA(IMP) 43685
- Site address
- UNIT 3 & 4, GATEWAY WEST, GREENFINCH WAY, NEWBURN, NEWCASTLE UPON TYNE, NE15 8NX, 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 [ 1.2.2 ] Batch certification [ 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 [ 1.5.1.5 ] Liquids for external use [ 1.5.1.6 ] Liquids for internal use [ 1.5.1.8 ] Other solid dosage forms [ 1.5.1.12 ] Suppositories [ 1.5.1.13 ] Tablets [ 1.5.1.17 ] Other non-sterile medicinal productsPowders [ 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 [ 2.2.2 ] Non-sterile 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
- This certificate is granted on the basis that the company has committed to restrict Primary and Secondary Packaging operations for IMPs performed at this site to Open-Label studies only. 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 · 86996e3f-7b9e-4b0e-a435-477920cb1610
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