Petrovax has an effective quality management system (QMS) in place officially certified to the ISO 9001:2015, and GMP standards. The QMS guarantees a high safety and efficacy level of the company’s products, and provides for quality control at each product lifecycle stage.
-
The QMS high-level performance is annually certified through comprehensive audits by ISO and GMP certification authorities.
-
Petrovax cooperates with approved raw and other material suppliers only.
-
The document management system provides for keeping track of all actions by the manufacturing and quality control personnel, both in real time and historically.
-
The company has an automated QMS training program in place based on the WebTutor, an education and professional development web portal providing each employee with individual QMS training and testing plans.
Quality Unit
Pharmaceutical safety and efficacy is provided for by raw and other material control as well as control of all manufacturing process stages — from API to finished products. The Quality Unit has 90+ employees.
Operating a spectrophotometer. The analyst plots a calibration line for product quality control
Raw material acceptance control. The analyst puts test samples into an autosampler
GMP certificates
The company’s
Annually, the company successfully passes numerous inspections by relevant Russian agencies, foreign regulatory authorities as well as acknowledged world pharma leaders (e.g. Pfizer, and Abbott).
Pharmacovigilance
A pharmacovigilance system is an efficient postmarketing product monitoring tool operated in compliance with the relevant international standards, and the Russian regulatory requirements. The company’s pharmacovigilance experts perform ongoing monitoring of pharmaceutical product efficacy and adverse effect data to ensure a proper safe drug use control.
