The pharmaceutical quality system at POLYSAN is the integrated system developed and supported in compliance with current requirements of GMP EU, ISO 9001, ISO 14001, ISO 18001.
The system requirements are aimed to all divisions of the company. Our target is to provide the consistent manufacture of high-quality and safe pharmaceutical products, meeting people’s needs for the effective medication. This is the priority for POLYSAN. The relevance of POLYSAN pharmaceutical quality system is ensured by continuous assessment of changing external requirements and consideration of ISPE, ICH, PDA recommendations.
POLYSAN commitment to quality has been fundamental from the very beginning. From 2007 such essential quality management elements as risk analysis and risk management, deviation control, change management are applied for our pharmaceutical production.
The required status of the pharmaceutical quality system is supported by the continuous multi-level staff training, team work, on-going analysis of the system efficiency by the company’s management, CAPA system.
The result of the effective quality system is the high quality of POLYSAN products. Quality management system (QMS) is put into practice at POLYSAN pharmaceutical plant. The system is established on the basis of regulatory and advisory legislative instruments from international regulating authorities PIC/S, PDA, FDA, ISPE, ICH. Its operation is based on over 900 internal documents created on the basis of GMP rules. GMP standards are the code of practice establishing how the production and quality control should be set to get a safe and effective product. GMP rules are the guarantee of the product quality.
The quality system effectiveness is continuously controlled by regulatory authorities. The compliance with GMP standards is verified by the certificate issued by results of the audit held by the State Service of Ukraine on Medicinal Products. The certificate of PIC/S member country is the highest quality appraisal of the manufacturer’s pharmaceutical products. High quality of POLYSAN products is verified by governmental awards, multi-centre clinical study results and lack of claims.