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12 August 2019

WHO conducted training on GMP inspectors at Darnitsa

12 August 2019

The World Health Organization (WHO) has selected Pharmaceutical Firm Darnitsa to conduct training of GMP (Good Manufacturing Practice) inspectors.

Trainers of the two-day training inspection were the auditors from Denmark and participated the staff of regulatory bodies of Azerbaijan, Kazakhstan and Moldova.

The training inspection was carried out in conditions and in accordance with the plan of a real audit for compliance with GMP requirements. It included a review of the pharmaceutical quality system, requirements for authorized persons, consideration of certain documentation.

Inspectors visited workshops of pharmaceutical solid dosage form manufacturing, the quality control laboratory and the warehouse center. They also examined all validation and qualification materials, registration dossiers of medical agents.

“The task of “Darnitsa” is not only to show a high level of quality standards and production processes. We assisted the inspectors in understanding how communication should be built between the party that is checking and the company”, commented Andrii Obrizan, the Director General of Darnitsa.

He reminded that Darnitsa has been complies to GMP requirements for 16 years. Over the past three years, the company has received 5 positive GMP compliance statements from inspectors of European countries.

The Denmark Inspector Tina Bay Brower, summing up results of the two-day training inspection, noted the good condition of production facilities, laboratories and storage premises of Darnitsa. At the same time, she emphasized that this inspection was educational by its nature and will not have regulatory consequences.

“For our training purposes, the possibility of visiting such enterprise such as Darnitsa where we can work in conditions of the real audit, is very important,” pointed Tina Bay Brower.

GMP is an integrated list of standards that must meet the production of medications in different countries of the world. The first version of the regulations for pharmaceuticals appeared in the USA in 1963. In 1969, the international GMP regulations were developed which WHO recommended for all countries of the world.

The World Health Organization was established in 1948. Its main objective is, together with governments and other partners, to ensure the highest attainable standard of health level for all inhabitants of the Earth. Today, more than 7,000 are staffed by 150 country offices, 6 regional offices and WHO headquarters is in Geneva.

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