Uk Mhra Gmp
ASTRAZENECA UK LIMITEDASTRAZENECA UK LIMITED – UK MHRA GMP Certificate UK MIA 17901 Insp GMP 17901/10117-0059[H]
Record Details
This Uk Mhra Gmp record concerns ASTRAZENECA UK LIMITED, with an inspection on April 2, 2026, issued by the MHRA, covering drugs.
- Company
- ASTRAZENECA UK LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- April 2, 2026
- Issued
- April 20, 2026
- MIA number
- UK MIA 17901
- Site address
- CHARTER WAY, SILK ROAD BUSINESS PARK, MACCLESFIELD, SK10 2NA, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Products [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) [ 1.1.1.5 ] Solids and implantsLHRH Agonist ( Zoladex) [ 1.1.1.6 ] Other aseptically prepared productsLHRH Agonist (Solids and Implants) [ 1.1.3 ] Batch certification [ 1.2 ] Non-sterile products [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) [ 1.2.1.13 ] TabletsAntioestrogen (Nolvadex) [ 1.2.2 ] Batch certification [ 1.5 ] Packaging [ 1.5.1 ] Primary packaging [ 1.5.1.1 ] Capsules, hard shell [ 1.5.1.13 ] Tablets [ 1.5.2 ] Secondary packaging [ 1.6 ] Quality control testing [ 1.6.1 ] Microbiological: sterility [ 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 [ 2.1.1 ] Microbiological: sterility [ 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 [ 2.2.1.2 ] Terminally sterilised [ 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
- Restrictions
- THIS GMP CERTIFICATE IS APPLICABLE TO OPERATIONS CONDUCTED IN: PHARMACEUTICAL PRODUCTION BUILDING (PPB), GLOBAL PACKING CENTRE (GPC), SPECIAL TABLETS FACILITY (STF), PHARMACEUTICAL PRODUCTION BUILDING 2 (PPB2), COPOLYMER PRODUCTION LABORATORIES (CPL), STERILE PRODUCTS PLANT 3 (SPP3 FORMULATION AND ASSEMBLY), STERILE PRODUCTS PLANT 4 (SPP4 FORMULATION AND ASSEMBLY), STERILE PRODUCTS PLANT 5 (SPP5 FORMULATION ONLY), QUALITY ASSURANCE BUILDING I / II (QAB), SITE ARCHIVE, WAREHOUSES. 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 · 584d326d-8f15-4982-8c7e-67454af9e89a
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