In September, Petrovax Pharm successfully passed a recertification audit of its Quality Management System (QMS) for compliance with GOST ISO 9001–2011 (ISO 9001:2008). The audit was performed by the Russian Register — Baltic Inspection LLC (a certification authority) with participation of the Chief State Inspectorate of the Federal Service for Surveillance in Healthcare and Social Development. The auditors rated high Petrovax’s QMS performance and efficacy.
Also in September, a scheduled audit by FSBI Research Center for Medical Product Assessment of the Russian Ministry of Health was performed. The audit yielded a positive opinion on compliance of the quality management system and production processes associated with Grippol plus flu vaccine.
Certification audits are one of the most important steps for maintaining Petrovax Pharm’s leadership in the field of product quality and competitiveness. Since foundation, the company has pursued a coherent policy on the implementation, maintenance, and continuous improvement of its manufacturing processes and QMS in compliance with GMP and ISO standards. To date, the company has successfully passed numerous QMS inspections by auditor commissions representing a variety of competent certification bodies.