Uk Mhra Gmp
DAINIPPON SUMITOMO PHARMA COMPANY LIMITEDDAINIPPON SUMITOMO PHARMA COMPANY LIMITED – UK MHRA GMP Certificate UK GMP 31789 Insp GMP 31789/377916-0003[H]
Record Details
This Uk Mhra Gmp record concerns DAINIPPON SUMITOMO PHARMA COMPANY LIMITED, with an inspection on November 29, 2011, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- November 29, 2011
- Issued
- March 20, 2012
- MIA number
- UK GMP 31789
- Site address
- 2200 OAZA TSURUSAKI, OITA-SHI, JP-870-0106, JAPAN
- Country
- JAPAN
- 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) [ 1.1.1.6 ] Other aseptically prepared productsBlended meropenem and sodium carbonate [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 1.6 ] Quality control testing [ 1.6.1 ] Microbiological: sterility [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products FU1 & FU2 plus utilities and laboratories used for Meropenem Meropenem sterile API manufacture Aseptic blending of Meropenem and Sodium Carbonate
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ID · e8b1a250-d6c0-4e92-b7ca-51810eea9d78
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