Uk Mhra Gmp
GENZYME CORPORATIONGENZYME CORPORATION – UK MHRA GMP Certificate UK GMP 11213 Insp GMP 11213/504470-0006[H]
Record Details
This Uk Mhra Gmp record concerns GENZYME CORPORATION, with an inspection on November 30, 2015, issued by the MHRA, covering biologics.
- Company
- GENZYME CORPORATION
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- November 30, 2015
- Issued
- March 29, 2016
- MIA number
- UK GMP 11213
- Site address
- 45, 51, 55, 74, 76 AND 80 NEW YORK AVENUE, FRAMINGHAM, 01701, UNITED STATES
- Country
- UNITED STATES
- Products
- Human Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.3 ] Biological medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.5 ] Biotechnology products [ 1.4 ] Other products or manufacturing activity [ 1.4.1 ] Manufacture of: [ 1.4.1.3 ] OtherInvestigational Medicinal Products [ 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 [ 1.6.4 ] Biological
- Restrictions
- The off site GMP warehousing and raw material testing operations carried out at Genzyme Northborough were inspected. Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products This inspection included the QC GMP testing activities carried out in Building 68 New York Avenue EU Products - Cerezyme, Fabrazyme, Myozyme and Thyrogen
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ID · 513208cb-d680-48e6-96ba-168fd6ff6013
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