Uk Mhra Gmp
SIGMA-ALDRICH CORPORATION - SAFC PHARMASIGMA-ALDRICH CORPORATION - SAFC PHARMA – UK MHRA GMP Certificate UK GMP 19057 Insp GMP 19057/11717-0001[H]
Record Details
This Uk Mhra Gmp record concerns SIGMA-ALDRICH CORPORATION - SAFC PHARMA, with an inspection on October 20, 2014, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- October 20, 2014
- Issued
- November 24, 2014
- MIA number
- UK GMP 19057
- Site address
- 3300 SOUTH SECOND STREET, ST LOUIS, 63118, 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) [ 1.1.1.6 ] Other aseptically prepared productsFerumoxytol drug product intermediate [ 1.4 ] Other products or manufacturing activity [ 1.4.1 ] Manufacture of: [ 1.4.1.3 ] OtherFerumoxytol drug substance [ 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 Manufacture of Ferumoxytol drug substance and drug product intermediate (sterile partially formulated aqueous colloidal drug product in bags).
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