Uk Mhra Gmp
MERCK SHARP & DOHME CORPORATIONMERCK SHARP & DOHME CORPORATION – UK MHRA GMP Certificate UK GMP 5591 Insp GMP 5591/6900985-0002[H]
Record Details
This Uk Mhra Gmp record concerns MERCK SHARP & DOHME CORPORATION, with an inspection on November 12, 2012, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- November 12, 2012
- Issued
- August 16, 2013
- MIA number
- UK GMP 5591
- Site address
- 770 SUMNEYTOWN PIKE, WEST POINT, 19486, 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) [ 1.1.2.5 ] Other terminally sterilised prepared productsSolvent/diluent, LACRISERT [ 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 [ 1.2.1.6 ] Liquids for internal use [ 1.2.1.8 ] Other solid dosage forms [ 1.2.1.13 ] Tablets [ 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 productsELSPAR ( L-Apariginase), Vaccines [ 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
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ID · 1fe72309-e02c-406d-92ee-ce9ae1fb0bca
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