Uk Mhra Gmp
BIOGEN U.S. CORPORATION (BIOGEN INCORPORATED)BIOGEN U.S. CORPORATION (BIOGEN INCORPORATED) – UK MHRA GMP Certificate UK GMP 22913 Insp GMP 22913/1404041-0005[H]
Record Details
This Uk Mhra Gmp record concerns BIOGEN U.S. CORPORATION (BIOGEN INCORPORATED), with an inspection on July 18, 2016, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- July 18, 2016
- Issued
- September 14, 2016
- MIA number
- UK GMP 22913
- Site address
- 900 DAVIS DRIVE, RESEARCH TRIANGLE PARK, 27709, 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 [ 1.2 ] Non-sterile products [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) [ 1.2.1.1 ] Capsules, hard shell [ 1.2.1.13 ] Tablets [ 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 Within the Parenteral Facility (Building 36) only Line 2 is authorised as Line 1 was not inspected
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ID · d2feba44-fe1a-4a7d-aa97-bf8c6968d57b
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