Jul 09, 2013

Farmak JSC received FDA’s approval for Validol

During 7-13 November, 2012 Farmak JSC was inspected by FDA* to ascertain that Validol tablets are manufactured for the U.S. market in compliance with the cGMP requirements.

Our Company has received a formal response saying that the inspection procedures are completed and Validol-related Production and Quality Systems are assessed as acceptable.

Olga Oleksiichuk, Quality Director says, “For Farmak, it was the first positive experience passing an FDA inspection, during which our specialists could observe FDA’s approaches to interrelated assessment of the six quality systems, including, quality assurance, production, quality control, maintenance and other systems. We saw that the major focus of FDA inspection was given to the issues that pose the biggest consumer safety concern”.

Our specialists have also gained valuable experience of communication with the inspectors and saw how important professionalism and teamwork are. At the same time, we are responsible to assure the continued compliance with the current Good Manufacturing Practice (сGMP).

Reference

*FDA (Food and Drug Administration) is a U.S. government regulatory agency responsible for controlling food and drugs. It issues manufacturing authorizations and registers the drugs for sale within the USA. It is also responsible for inspections of drug and substance manufacturers.

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