Uk Mhra Gmp
ZYDUS HOSPIRA ONCOLOGY PRIVATE LIMITEDZYDUS HOSPIRA ONCOLOGY PRIVATE LIMITED – UK MHRA GMP Certificate UK GMP 32340 Insp GMP 32340/409199-0007[H]
Record Details
This Uk Mhra Gmp record concerns ZYDUS HOSPIRA ONCOLOGY PRIVATE LIMITED, with an inspection on November 26, 2018, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- November 26, 2018
- Issued
- February 20, 2019
- MIA number
- UK GMP 32340
- Site address
- PLOT NO. 3, PHARMEZ-SPECIAL ECONOMIC ZONE, SARKHEJ BAVLA HIGHWAY, N.H NO. 8A, MATODA, TALUKA SANAND, AHMEDABAD, IN 382213, INDIA
- Country
- INDIA
- 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) [ 1.1.1.2 ] Lyophilisates [ 1.1.1.4 ] Small volume liquids [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms) [ 1.1.2.3 ] Small volume liquids [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 1.4.2.2 ] Dry heat [ 1.4.2.3 ] Moist heat [ 1.5 ] Packaging [ 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
- Restrictions
- Inspection scope covered both Line 1 and Line 2 filling operations. Lyophilised products on Line 1 only. Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products Inspection scope covered both Line 1 and Line 2 filling operations. Lyophilised products on Line 1 only.
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ID · 53c96fce-282f-4ca0-901b-f130b7b72367
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