Petrovax has the Quality Management System (QMS) in place officially certified by ISO 9001:2015, and GMP standards. The QMS guarantees high safety and efficacy of manufactured products, allowing for quality control at each stage of the product life-cycle.
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A high level of QMS performance is annually certified in large-scale audits by ISO and GMP certification authorities.
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The Company only cooperates with approved raw and other material suppliers.
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The document management system allows tracking of 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, providing each employee with individual QMS training and testing plans.
Quality service
The safety and efficacy of pharmaceutical products are guaranteed by the control of raw and other materials as well as all manufacturing process stages: from an API to a finished product. The Quality Service staff is more than 90 people.
Operating a spectrophotometer. The analytical chemist is plotting a calibration line for product control.
Raw material incoming control. The analytical chemist is putting test samples into an autosampler.
Pharmacovigilance
Pharmacovigilance is an efficient instrument of postmarketing medicine product surveillance, which is carried out in the company 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.
