Uk Mhra Gmp
SMITHKLINE BEECHAM LTD T\A SMITHKLINE BEECHAM PHARMACEUTICALSSMITHKLINE BEECHAM LTD T\A SMITHKLINE BEECHAM PHARMACEUTICALS – UK MHRA GMP Certificate UK MIA 10592 Insp GMP 10592/1524-0022[H]
Record Details
This Uk Mhra Gmp record concerns SMITHKLINE BEECHAM LTD T\A SMITHKLINE BEECHAM PHARMACEUTICALS, with an inspection on December 20, 2024, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- December 20, 2024
- Issued
- December 20, 2024
- MIA number
- UK MIA 10592
- Site address
- SHEWALTON ROAD, IRVINE, KA11 5AP, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.2 ] Non-sterile products [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) [ 1.2.1.17 ] Other non-sterile medicinal productsActive intermediate Potassium Clavulanate/ Amoxicillin Trihydrate 1:1 non sterile mix, Blending of APIs. [ 1.6 ] Quality control testing [ 1.6.3 ] Chemical/Physical
- 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. Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products Intermediate tBA Potassium Clavulanate (Neat) Potassium Clavulanate / Silicon Dioxide blend Potassium Clavulanate / Microcrystalline Cellulose blend Potassium Clavulanate / Amoxicillin blend The manufacture of 6-APA was not included in the scope of the inspection.
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ID · 7fa620e8-495f-41ae-8a32-f1ff63ad5e6b
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