Uk Mhra Gmp
KYOWA HAKKO KIRIN COMPANY LIMITEDKYOWA HAKKO KIRIN COMPANY LIMITED – UK MHRA GMP Certificate UK GMP 5129 Insp GMP 5129/765573-0002[H]
Record Details
This Uk Mhra Gmp record concerns KYOWA HAKKO KIRIN COMPANY LIMITED, with an inspection on December 5, 2011, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- December 5, 2011
- Issued
- March 15, 2012
- MIA number
- UK GMP 5129
- Site address
- FUJI PLANT, 1188 SHIMOTOGARI, NAGAIZUMI-CHO, SUNGO-GUN, JP-411-8731, JAPAN
- Country
- JAPAN
- 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 [ 1.1.1.5 ] Solids and implants [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 1.4.2.2 ] Dry heat [ 1.4.2.3 ] Moist heat [ 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
- Restrictions
- THE SCOPE OF THE INSPECTION WAS LIMITED TO MANUFACTURE AND PACKAGING OF STERILE PRODUCTS, SPECIFICALLY MITOMYCIN C ON #1 VIAL FILLLING LINE AND ASPARAGINASE ON #7 VIAL FILLING LINE. THESE ARE LOCATED ON THE 2ND FLOOR OF PHARMACEUTICAL PLANT NUMBER 1. PACKAGING ACTIVITIES ON 1V LINE AND 100V LINE IN PHARMACEUTICAL PLANT NUMBER 2 WERE ALSO INSPECTED. QC LABORATORIES AND RELEVANT WAREHOUSES WERE ALSO INCLUDED. Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products THE SCOPE OF THE INSPECTION WAS LIMITED TO MANUFACTURE AND PACKAGING OF STERILE PRODUCTS, SPECIFICALLY MITOMYCIN C ON #1 VIAL FILLLING LINE AND ASPARAGINASE ON #7 VIAL FILLING LINE. THESE ARE LOCATED ON THE 2ND FLOOR OF PHARMACEUTICAL PLANT NUMBER 1. PACKAGING ACTIVITIES ON 1V LINE AND 100V LINE IN PHARMACEUTICAL PLANT NUMBER 2 WERE ALSO INSPECTED. QC LABORATORIES AND RELEVANT WAREHOUSES WERE ALSO INCLUDED. FILLING: VIAL LINE 1 AND VIAL LINE 7 WERE INSPECTED. PACKAGING ACTIVITIES ON 1V LINE AND 100V LINE WERE INSPECTED. QC LABORATORIES ASSOCIATED WITH THE TESTING OF MITOMYCIN C AND ASPARAGINASE PRODUCTS WERE INSPECTED. MITOMYCIN C AND ASPARAGINASE WERE IN SCOPE OF INSPECTION
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ID · ee32bc56-7111-40ce-8d46-8de0a7731214
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