Uk Mhra Gmp
SIGMA-TAU PHARMASOURCE INCORPORATEDSIGMA-TAU PHARMASOURCE INCORPORATED – UK MHRA GMP Certificate UK GMP 39755 Insp GMP 39755/13359-0007[H]
Record Details
This Uk Mhra Gmp record concerns SIGMA-TAU PHARMASOURCE INCORPORATED, with an inspection on March 12, 2012, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- March 12, 2012
- Issued
- June 29, 2012
- MIA number
- UK GMP 39755
- Site address
- 6925 GUION ROAD, INDIANAPOLIS, 46268, UNITED STATES
- Country
- UNITED STATES
- 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) [ 1.1.1.4 ] 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 [ 1.6 ] 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 The site is not considered acceptable for the aseptic filling of eye drop products using the small scale ophthalmic filler (Capmatic) without performing a further inspection. This is due to proposals for operation and siting of the equipment not being complete at the time of this inspection.
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ID · d9ded8cb-c6c8-4d43-9804-22daed0b3ef4
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