Uk Mhra Gmp
BEN VENUE LABORATORIES INCORPORATEDBEN VENUE LABORATORIES INCORPORATED – UK MHRA GMP Certificate UK GMP 6105 Insp GMP/IMP 6105/16949-0020[H]
Record Details
This Uk Mhra Gmp record concerns BEN VENUE LABORATORIES INCORPORATED, with an inspection on August 6, 2012, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP/IMP
- Inspection date
- August 6, 2012
- Issued
- August 28, 2013
- MIA number
- UK GMP 6105
- Site address
- 300 NORTHFIELD ROAD, BEDFORD, 44146, 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) [ 1.1.1.2 ] Lyophilisates [ 1.1.1.4 ] Small volume liquids [ 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 [ 1.5 ] Packaging [ 1.5.2 ] Secondary packaging [ 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 South Facility and Phase IV:- The scope of this GMP certificate is limited to medicinal products essential to public health use and with a valid marketing authorisation approved before 27th June 2011 North Facility:- The scope of the certificate is limited to Caelyx (refer to CHMP EMA/912026/2011) and any other nationally authorised medically essential product, as determined by the National Competent Authority.
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ID · 6dc43dc4-481e-4748-af62-513d4a1dd744
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