Quality Management and Consulting in PharmaTech
The Pharmaceutical Quality System is a management system to direct and control a pharmaceutical company with regard to quality. In PharmaTech effective Pharmaceutical Quality System is in place with the objective of ensuring that medical products are of the quality, required for their intended use. The manufacturing process is under the strict policies and procedures of GMP standards. The installation of modular pharmaceutical equipment and technology was carried out by IPM-UPSA of Bordeaux, France (then a Bristol Myers Squibb company) according to European GMP standards in 1997. Till now the management including quality issues is done in association with our Western European partners. The current quality management system of the company is developed, documented, and implemented further to the requirements of GMP, GDP, GVP, and ISO 9001-2008 standards, covering the activities referring to production, documentation, quality control, validation and qualification, material management and warehousing, distribution, risk management, self-inspection, corrective/preventive actions, batch release, outsourced activity, supplier audit and monitoring, improvements, etc. Pharmatech CJSC has a PV system and provides pharmacovigilance services in Armenia for the drugs manufactured by other companies, including (but not limited to) the provision of safety data exchange, reconciliation reporting, individual case reporting, and literature survey. The PV services to be provided by the company are further to the Pharmacovigilance agreements as an addition to the sales contract or as a separate Contract. The pharmacovigilance system is managed by the QPPV assigned by the company.