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Uk Mhra Gmp
•QILU TIANHE PHARMACEUTICAL CO LTD•June 26, 2011

QILU TIANHE PHARMACEUTICAL CO LTD – UK MHRA GMP Certificate UK GMP 23083 Insp GMP 23083/38473-0005[H]

Record Details

This Uk Mhra Gmp record concerns QILU TIANHE PHARMACEUTICAL CO LTD, with an inspection on June 26, 2011, issued by the MHRA, covering drugs.

Company
QILU TIANHE PHARMACEUTICAL CO LTD
Compliance status
GMPC
Certificate type
GMP
Inspection date
June 26, 2011
Issued
November 22, 2011
MIA number
UK GMP 23083
Site address
WORKSHOP 8, 849 DONGJIA TOWN, LICHENG DISTRICT, JINAN CITY, SHANDONG, CN-250105, CHINA
Country
CHINA
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) [ 1.1.1.2 ] Lyophilisates [ 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 Workshops 4 and 7 were inspected for the production of sterile APIs Production lines 1 & 3 of Workshop 4 Production lines 1,2 & 3 of Workshop 7 Piperacillin/Tazobactam sterile API
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ID · 642ae68c-6236-45f4-9b72-c990b559fc06

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