MHARA has publised GxP data integrity guidance for the industry. It addresses fundamental failures identified by MHRA and international regulatory partners during GLP, GCP, GMP and GDP inspections; many of
This guidance document has been prepared to aid vaccine manufacturers in the preparation and performance of the validation studies required by Good Manufacturing Practices (GMP) of the World Health Organization
The Ministry of Health of Ukraine issued an order #896 concerning the renewed GMP-certificate by vendors for selling drugs on the territory of Ukraine. "Good manufacturing practice" or "GMP" is
One of the most frequently asked questions recently asks how to extend the Beyond-Use Date (BUD) of compounded sterile preparations (CSPs). Eric S. Kastango, RPh, MBA, FASHP, reviewed the requirements
19-20 May 2010 in Geneva a meeting of the Executive Committee of the PIC / S was held. The Ukrainian delegation, headed by Alexei Soloviev, Chairman of the State Inspectorate
There are many risks that may threaten any organization by disrupting its business processes. The spectrum of risks and threats may start as a leakage in the supply pipe and
