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A Successful Inspection by the US Food and Drug Administration (FDA) at PLIVA

A Successful Inspection by the US Food and Drug Administration (FDA) at PLIVA

In October 2013, PLIVA HRVATSKA, a member of the Teva Group, was inspected by the United States Food and Drug Administration (FDA).

The FDA reviewed processes at the production site in Zagreb, and the main objective of the inspection was to establish whether the products manufactured in PLIVA's facilities comply with Good Manufacturing Practice (GMP) requirements. This year's inspection has covered the production of oral solid forms and semi-solid forms, as well as ancillary facilities such as warehousing, technical services, quality control laboratories and related processes.

 The main objectives of inspections are to protect human health through the control of medicinal products for human use. The FDA inspection, known for its rigorous regulatory requirements and control of the production of active pharmaceutical ingredients and drug products for the U.S. market, was successfully completed in the end of October.

During the FDA audit, the Ukrainian Drug Control Agency, which is active with the Ministry of Public Health of Ukraine, was also present. “This successful inspection represents positive feedback on the controls of our products and processes”, said Tatjana Ilić, Quality Zagreb Director.

 PLIVA is the only FDA-approved manufacturer of active pharmaceutical ingredients and finished dosage forms in Croatia, and it has been audited by the FDA more than twenty times since 1965. These facilities supply products not only in Croatia but also to the most demanding pharmaceutical markets worldwide.

“PLIVA’s production processes are regularly audited by foreign regulatory agencies and by the Croatian Agency for Medicinal Products and Medical Devices. The successfully completed FDA inspection is yet another proof that PLIVA has state-of-the-art production processes. We invested over USD 100 million in the construction of and the equipment for our new production facilities for oral solid forms, and I am especially glad that they were also successfully audited. In the interest of all our patients, we regard compliance with the highest quality standards, which is achieved thanks to our experts, as our top priority”, emphasized Tihomir Orešković, President of PLIVA’s Management Board.

 

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