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Uk Mhra Gmp
•DEY PHARMA LP•July 19, 2010

DEY PHARMA LP – UK MHRA GMP Certificate UK GMP 21847 Insp GMP 21847/23796-0005[H]

Record Details

This Uk Mhra Gmp record concerns DEY PHARMA LP, with an inspection on July 19, 2010, issued by the MHRA, covering drugs.

Company
DEY PHARMA LP
Compliance status
GMPC
Certificate type
GMP
Inspection date
July 19, 2010
Issued
February 4, 2011
MIA number
UK GMP 21847
Site address
2751 NAPA VALLEY CORPORATE DRIVE, NAPA, 94558, UNITED STATES
Country
UNITED STATES
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 Inhalation Solutions [ 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 Only Building 1 aseptic manufacture (Suite 3/3A line 15) was inspected during this inspection. Only Building 1 aseptic manufacture (Suite 3/3A line 15) was inspected during this inspection. Only Building 1 aseptic manufacture (Suite 3/3A line 15) was inspected during this inspection. Only microbiology laboratory in building 1 was inspected during this inspection.
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ID · b067871d-ee28-47d1-9208-c42815385f55

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