Uk Mhra Gmp
MERCK & CO. INCORPORATEDMERCK & CO. INCORPORATED – UK MHRA GMP Certificate UK GMP 13736 Insp GMP 13736/4246-0002[H]
Record Details
This Uk Mhra Gmp record concerns MERCK & CO. INCORPORATED, with an inspection on August 24, 2009, issued by the MHRA, covering drugs.
- Company
- MERCK & CO. INCORPORATED
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- August 24, 2009
- Issued
- October 5, 2009
- MIA number
- UK GMP 13736
- Site address
- MERCK MANUFACTURING DIVISION, 2778 SOUTH EAST SIDE HIGHWAY, ELKTON, 22827, 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) [ 1.1.1.5 ] Solids and implants [ 1.1.1.6 ] Other aseptically prepared productsImipenem, cilastatin, sodium bicarbonate bulk sterile powders, PRIMAXIN [ 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 Secondary packaging not inspected. Aseptically prepared solids limited to preparation and filling of sterile powders.
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ID · 051f8492-05b7-48b6-9914-7329a67d659e
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