Uk Mhra Gmp
OSO BIOPHARMACEUTICALS MANUFACTURING LLCOSO BIOPHARMACEUTICALS MANUFACTURING LLC – UK MHRA GMP Certificate UK GMP 35167 Insp GMP 35167/916379-0005[H]
Record Details
This Uk Mhra Gmp record concerns OSO BIOPHARMACEUTICALS MANUFACTURING LLC, with an inspection on June 12, 2017, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- June 12, 2017
- Issued
- August 25, 2017
- MIA number
- UK GMP 35167
- Site address
- 4272 BALLOON PARK ROAD, ALBUQUERQUE, 87109, 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) [ 1.1.1.1 ] Large volume liquids [ 1.1.1.2 ] Lyophilisates [ 1.1.1.4 ] Small volume liquids [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms) [ 1.1.2.1 ] Large volume liquids [ 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 EU products - Prialt, NeuroBloc, Cubicin and Aloxi; UK product - AmBisome (PL 16807/0001)
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ID · f42da4b2-f74a-4399-8575-26c273e15b71
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