Uk Mhra Gmp
GENZYME CORPORATIONGENZYME CORPORATION – UK MHRA GMP Certificate UK GMP 11213 Insp GMP 11213/5707921-0005[H]
Record Details
This Uk Mhra Gmp record concerns GENZYME CORPORATION, with an inspection on November 7, 2016, issued by the MHRA, covering drugs.
- Company
- GENZYME CORPORATION
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- November 7, 2016
- Issued
- December 16, 2016
- MIA number
- UK GMP 11213
- Site address
- 1125 PLEASANT VIEW TERRACE, RIDGEFIELD, 07657, 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) [ 1.1.1.4 ] 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: [ 1.4.2.3 ] Moist heat [ 1.6 ] Quality control testing [ 1.6.1 ] Microbiological: sterility [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical
- Restrictions
- Aseptic filling is only authorized on line H6 in room 181. Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products Aseptic filling is only authorized on line H6 in room 181.
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ID · 78f3d075-73c2-43c4-b85c-b1b65473120b
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