Uk Mhra Gmp
STRIDES ARCOLAB LIMITED - SPECIALTY FORMULATION FACILITYSTRIDES ARCOLAB LIMITED - SPECIALTY FORMULATION FACILITY – UK MHRA GMP Certificate UK GMP 20003 Insp GMP 20003/1275284-0003[H]
Record Details
This Uk Mhra Gmp record concerns STRIDES ARCOLAB LIMITED - SPECIALTY FORMULATION FACILITY, with an inspection on September 3, 2012, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- September 3, 2012
- Issued
- May 9, 2013
- MIA number
- UK GMP 20003
- Site address
- PLOT NO 284/B1, BOMMASANDRA JIGANI LINK ROAD INDUSTRIAL AREA, JIGANI HOBLI, ANEKAL TALUK, BANGALORE, IN-560105, 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 [ 1.1.1.6 ] Other aseptically prepared productsSterile Dry Powder Injectables [ 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 [ 1.4.2.3 ] Moist heat [ 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 Speciality Formulation Facility Inspected not other buildings QC and Microbiology laboratories were inspected The sterile manufacturing facilities suites 1,2 and 3 were inspected. The primary focus of this inspection was Vancomycin Injection in vials. However, a general inspection of aseptic filling, lyophilisation but NOT dry powder filling was undertaken. Autoclaves were examined for suitability for liquid and porous load cycles.
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ID · 4714008f-25d5-4173-bb40-5f0c21bc5143
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