Petrovax Quality Policy is implemented through a comprehensive Quality Management System in compliance with ISO 9001:2015 and GMP standards.
The QMS guarantees high safety and efficacy of manufactured products, allowing for quality control throughout their life-cycle from research to development, manufacturing, and distribution of medicines.
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The high level of QMS performance is monitored and regularly reviewed in large-scale audits by ISO and GMP certification authorities.
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The Company cooperates only with approved raw and other material suppliers.
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The document management system allows tracking of the performance results of all manufacturing and quality control personnel both in real time and historically.
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The Company has an automated QMS training system based on WebTutor, a training and development portal. The system ensures individual QMS training and testing plans for each employee.
Quality service
The safety and efficacy of pharmaceutical products are guaranteed by the control of raw and other materials as well as continuous monitoring at all stages of the manufacturing process: from an API to a finished product. The Quality Service staff comprises more than 90 people.
Operating a spectrophotometer. The analytical chemist is plotting a calibration line for medicine product control.
Incoming raw material control. The analytical chemist is putting test samples into an autosampler.
Pharmacovigilance
Pharmacovigilance is an efficient instrument to monitor a medicinal product after it has been released on the market. The Company performs pharmacovigilance in compliance with international standards and Russian regulatory requirements. To ensure medicine product safety surveillance, the Company’s responsible employees are involved in continuous monitoring of information in regards to medicine product-related adverse reactions and medicine product efficacy.
