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Uk Mhra Gmp
•HEMOFARM A.D.•April 29, 2020

HEMOFARM A.D. – UK MHRA GMP Certificate UK GMP 16929 Insp GMP 16929/8740-0002[H]

Record Details

This Uk Mhra Gmp record concerns HEMOFARM A.D., with an inspection on April 29, 2020, issued by the MHRA, covering drugs.

Company
HEMOFARM A.D.
Compliance status
GMPC
Certificate type
GMP
Inspection date
April 29, 2020
Issued
May 7, 2020
MIA number
UK GMP 16929
Site address
BEOGRADSKI PUT BB, VRSAC, RS-26300, SERBIA
Country
SERBIA
Products
Human Medicinal Products
Manufacturing operations
1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Products [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms) [ 1.1.2.3 ] Small volume liquids [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.3 ] Moist heat
Restrictions
This certificate is issued based on a remote inspection of GMP compliance during COVID-19 travel restrictions. The scope of the remote inspection was limited to activities relating to terminal sterilisation of small volume parenteral products in ampoules in building 23 (PIP) and should be considered in conjunction with GMP certificates reference: DE_HE_01_GMP_2018_0067 and DE_HE_01_GMP_2019_0154 A risk-based site inspection programme remains in force. Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products Building 23 (PIP)
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ID · 3238325e-4ec3-4190-bb05-c70eeff87edf

Other documents for HEMOFARM A.D.
  • WARNING_LETTER - 2011-11-22November 22, 2011

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