Dedication to Quality is our core value and a competitive advantage.
The Quality Policy of Bionika Pharmaceuticals follows the cGMP requirements, as well as requests and needs of the customers.
Quality Assurance Department, through its documented system, is responsible for organization and management of the activities related to the quality, in order to make sure that all aspects, which individually or together influence the product quality, have been taken into consideration.
By the implementation of the GMP requirements in our production and quality control activities, we provide safe and efficient products, fit to their intended purpose.
Medicinal products, manufactured by Bionika Pharmaceuticals, are not sold or supplied before a Qualified Person has certified that each production batch has been produced and controlled in accordance with the requirements of the Marketing Authorisation and any other regulations relevant to the production, control and release of medicinal products (according to EU GMP Guide, Annex 16).
- Quality Assurance Department fulfills its function by involving and managing in following activities:
Obtaining appropriate quality certificates from authorized bodies; - Development and control of an appropriate documentation system;
- Validation and qualification activities;
- Deviations, non-compliances, OOS, OOT,OOE results;
- Change control;
- Compliance and batch recall;
- Corrective / preventive actions;
- Trainings of the personnel;
- Self-inspection;
- Approval of suppliers; outsourced activities (Quality Agreements, Audits)
- Annual quality review for each medicinal product (PQR);
- Accompanying the external GMP inspections.
