Uk Mhra Gmp
PHARMACEUTICS INTERNATIONAL INCORPORATEDPHARMACEUTICS INTERNATIONAL INCORPORATED – UK MHRA GMP Certificate UK GMP 22917 Insp GMP 22917/8721389-0002[I]
Record Details
This Uk Mhra Gmp record concerns PHARMACEUTICS INTERNATIONAL INCORPORATED, with an inspection on February 22, 2016, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- February 22, 2016
- Issued
- June 15, 2016
- MIA number
- UK GMP 22917
- Site address
- 103 BEAVER COURT, COCKEYSVILLE, 21030, UNITED STATES
- Country
- UNITED STATES
- Products
- Human Investigational Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Investigational Medicinal 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 [ 1.4.2.2 ] Dry heat [ 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 [ 1.6.4 ] Biological
- Restrictions
- The scope of manufacturing / testing covered this GMP certificate is limited to medicinal products confirmed by the relevant national competent authority as critical to public health, and with a valid marketing authorisation approved naming the site address. The GMP certificate may also not be used to support marketing authorisation applications made to a competent authority after the date of issuance. The certificate will not be considered valid after 30 June 2017.
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ID · f809fc02-1c3e-43a8-9245-5ec0ef842a1d
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