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Galychpharm passed PIC/S-supervised audit

Galychpharm passed PIC/S-supervised audit

30 January 2019 | News

Galychpharm undergone a routine GMP compliance inspection by the State Inspectorate for Quality Control of Medicines . The inspection was initiated by Galychpharm to extend the validity of its GMP certificate.

As suggested by the State Inspectorate, a representative of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) was involved to evaluate the work of the State Inspectorate.. The representative was tasked with evaluating performance and qualification of the State Inspectorateand Ukrainian Pharmaceutical Quality Institute inspectors as a part of Ukraine’s PIC/S membership verification.

Summing up the audit findings, the PIC/S representative highlighted the level of Galychpharm’s production streamlining, Pharmaceutical Quality System, and personnel qualification. The validity of GMP certificate for the producer’s Bottling Area and Ampoule Packing Area thus was extended for the third time since their commissioning in December 2012.

Ukraine’s State Inspectorate for Quality Control of Medicines became a member of the Pharmaceutical Inspection Co-operation Scheme in 2011. PIC/S is a unique international organization that connects GMP inspectorates of its member countries to align GMP standards, develop inspection rules, and build trust among inspectors.

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