Quality of Drugs Manufactured in ALKALOID AD Skopje

In order to remain consistent with our primary commitment, to ensure high quality, safety and efficacy of the drugs manufactured in ALKALOID AD Skopje, we have developed a straightforward and correctly implemented Pharmaceutical Quality System, which represents the fully documented Quality Assurance. Its efficiency is regularly monitored, with participation and full dedication, by ALKALOID’s staff, by our company suppliers and distributors.

Pharmaceutical Quality Assurance is an advanced concept, appropriate for the production of medicinal products, which covers all issues that individually or collectively affect the quality of products. It is an aggregate of all organized procedures and activities in the company, aimed at ensuring that all medicinal products are of high quality, safe and effective for their use and compliant with the marketing authorization requirements.

The organizational unit Pharmaceutical Quality Assurance comprises the following activities:

  • Correct implementation of the Procedure for Batch Release in compliance with the Macedonian legislation on drugs;
  • Issuance of a corresponding Certificate of Quality;
  • Developing annual review of medicinal products;
  • Implementation, maintenance, supervision and improvement of the Environmental System and Quality, in compliance with cGMP, ISO 9001 и ISO 14001;
  • Document Management System application at all levels of document hierarchy;
  • Preparation and implementation of internal quality controls which are aimed to provide regular assessment of the efficacy and applicability of the Pharmaceutical Quality Assurance System;
  • Approval of pharmaceutical, chemical and biological documentation for registration;
  • Change control procedure management;
  • Approval of validation and qualification documentation;
  • Handling and researching nonconformities and deviations ( if any);
  • Handling product complaints (if any);
  • Assignment and implementation of corrective/preventive measures;
  • Assessment, check and approval of suppliers;
  • Implementation of training programs, basic and intermediate level training and ensuring its proper realization (periodical training assessment);
  • Participation in developing and approving Quality Agreements in cases of subcontracted production and their analysis;
  • Accompanying DPP inspections/ Quality Controls.