Uk Mhra Gmp
LONZA BIOLOGICSLONZA BIOLOGICS – UK MHRA GMP Certificate UK GMP 18601 Insp GMP 18601/11093-0002[H]
Record Details
This Uk Mhra Gmp record concerns LONZA BIOLOGICS, with an inspection on June 14, 2010, issued by the MHRA, covering biologics.
- Company
- LONZA BIOLOGICS
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- June 14, 2010
- Issued
- October 21, 2010
- MIA number
- UK GMP 18601
- Site address
- 101 INTERNATIONAL DRIVE, PEASE INTERNATIONAL TRADEPORT, PORTSMOUTH, 03801, UNITED STATES
- Country
- UNITED STATES
- Products
- Human Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.2 ] Non-sterile products [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) [ 1.2.1.6 ] Liquids for internal use [ 1.2.1.17 ] Other non-sterile medicinal productsBulk low bioburden API or formulation [ 1.3 ] Biological medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.5 ] Biotechnology products [ 1.3.1.6 ] Human or animal extracted products [ 1.3.1.8 ] Other biological medicinal productsmonoclonal antibodies and recombinant proteins produced from mammalian cell culture [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 1.4.3 ] OtherAseptic filtration of bulk formulation (low bioburden) for filling elsewhere; Autoclaves used for ma [ 1.6 ] Quality control testing [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical [ 1.6.4 ] Biological Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products Approved for QC testing by Biological, Chemical/Physical and Microbiological tests on API and Finished product. Stability testing also approved. Approved for the manufacture of immunological products, monoclonal antibodies and other proteins manufactured with recombinant DNA technology. Approved to manufacture cell banks.
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ID · 8d791523-84c5-4322-b48a-d7bdc992d81c
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