Uk Mhra Gmp
CATALENT CTS (KANSAS CITY) LLCCATALENT CTS (KANSAS CITY) LLC – UK MHRA GMP Certificate UK GMP 45817 Insp GMP 45817/13792392-0001[H]
Record Details
This Uk Mhra Gmp record concerns CATALENT CTS (KANSAS CITY) LLC, with an inspection on January 11, 2016, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- January 11, 2016
- Issued
- February 12, 2016
- MIA number
- UK GMP 45817
- Site address
- 10245 HICKMAN MILLS DRIVE, KANSAS CITY, 64137, UNITED STATES
- Country
- UNITED STATES
- Products
- Human Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.2 ] Non-sterile products [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) [ 1.2.1.1 ] Capsules, hard shell [ 1.2.1.13 ] Tablets [ 1.5 ] Packaging [ 1.5.1 ] Primary packaging [ 1.5.1.1 ] Capsules, hard shell [ 1.5.1.13 ] Tablets [ 1.5.1.17 ] Other non-sterile medicinal productsSoft Gels [ 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 [ 1.6.4 ] Biological Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products The inspection covered manufacturing, QC and stability testing, activities in building A, the Microbiology laboratories In building B, storage and manufacturing activities In building E and primary and secondary packaging in building P.
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