Pharmaceutical Quality Assurance

Pharmaceutical Quality Assurance

Concept and responsibilities

In order to remain consistent to our primary determination - that is to provide high quality of our products - we have established simple and correctly implemented system for Pharmaceutical quality assurance that is fully documented. Its efficiency is subject of permanent monitoring with participation and full dedication of our staff in the numerous sections and all the relevant levels in the profit center, by the suppliers and distributors of the Company.

The PQA is a high ranking concept, appropriate for production of medical products that covers all issues which can individually or collectively impact the quality of the products. It is a summary of all organizational arrangements composed in order to ensure that all the medical products are of high quality, safe and efficient for use, and they also correspond to the marketing authorization requirements.

The organizational unit of Pharmaceutical quality assurance comprises the following activities:

  • Appropriate implementation of the Procedure for batch release in compliance with the Macedonian legislation on drugs;
  • Issuing appropriate Quality Certificate;
  • Developing annual reviews on the medical products;
  • Implementation, maintenance, surveillance and improvement of the quality and the Environment System, in compliance with cGMP, ISO 9001 and ISO 14001;
  • Documents management system on all levels of the document hierarchy;
  • Development and implementation of internal quality audits for purpose of verification of the efficiency and application of the System for Pharmaceutical Quality Assurance;
  • Approval of pharmaceutical, chemical and biological documentation for registration;
  • Managing the Change Control procedure;
  • Approval of documentation for validation and qualification;
  • Research and management of deviations and results beyond the specifications (if any);
  • Managing complaints and recalls for products (if any);
  • Defining and implementation of corrective/preventive measures;
  • Evaluation, verification and approval of suppliers;
  • Implementation of training programs, basic and middle training levels, and its appropriate delivery (periodic evaluation of the training);
  • Involvement in development and approval of the Quality Agreements in case of Contractual production and analysis;
  • Accompanying external GMP inspections/quality controls.