Uk Mhra Gmp
EISAI MANUFACTURING LIMITEDEISAI MANUFACTURING LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 32301 Insp GMP/IMP 32301/726219-0013[I]
Record Details
This Uk Mhra Gmp record concerns EISAI MANUFACTURING LIMITED, with an inspection on July 3, 2025, issued by the MHRA, covering drugs.
- Company
- EISAI MANUFACTURING LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP/IMP
- Inspection date
- July 3, 2025
- Issued
- July 3, 2025
- MIA number
- UK MIA(IMP) 32301
- Site address
- EUROPEAN KNOWLEDGE CENTRE, MOSQUITO WAY, HATFIELD, AL10 9SN, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Investigational Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Investigational Medicinal Products [ 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) [ 1.2.1.13 ] Tablets [ 1.3 ] Biological investigational medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.5 ] Biotechnology products [ 1.5 ] Packaging [ 1.5.1 ] Primary packaging [ 1.5.1.13 ] Tablets [ 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 [ 2.1.3 ] Chemical/Physical [ 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
- 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 · c44d9773-d2b5-4e67-8961-1fdbcfe8a730
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