Uk Mhra Gmp
SAVIOR LIFETEC CORPORATION - TAINAN SITESAVIOR LIFETEC CORPORATION - TAINAN SITE – UK MHRA GMP Certificate UK GMP 34886 Insp GMP 34886/834264-0008[H]
Record Details
This Uk Mhra Gmp record concerns SAVIOR LIFETEC CORPORATION - TAINAN SITE, with an inspection on October 10, 2016, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- October 10, 2016
- Issued
- July 4, 2017
- MIA number
- UK GMP 34886
- Site address
- BLOCK A/B, 11 DA-SHUEN 9TH ROAD, XINSHI DISTRICT, TAINAN CITY, TW-74145, TAIWAN
- Country
- TAIWAN
- 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 productsSterile bulk API [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 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 Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products The inspection covered the aseptic manufacture of the API and the blending and packaging of Meropenem but NOT the manufacture of the basic API under part II of the EU GMP guide.
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ID · 8d531a1e-a498-4495-b81f-b2d87da94e1a
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