Quality Assurance of ALKALOID AD Skopje is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the sum total of the organized arrangements made with the objective of ensuring that products are of the quality, safety and efficacy required for their intended use and comply with the requirements of the product quality specification and Marketing Authorization.

The organizational unit Quality assurance incorporates the following activities:

• Complete implementation of the Integrated Management System (IMS) in ALKALOID AD Skopje and daughter companies of Alkaloid, according to the requirements of the relevant law and regulations (cGMP), standards ISO 9001, ISO 14001, ISO 45001, ISO 13485, HACCP, FSSC 22000 as well as all applicable directives and legislation;

• Compliance and implementation of IMS on corporate level (ALKALOID AD Skopje and daughter companies) in the area of quality, ecology, pharmacovigilance, materiovigilance, clinical trials, safety and health at work;

• Monitoring of implementation of the regulatory requirements, cGMP, guidelines, applicable standards along with the changes in the requirements, to facilitate timely and correct implementation within the IMS;

• Organization and participation in the process Management Review of IMS;

• Organization and implementation of internal audits/self-inspections, organization and active participation during external audits and inspection in ALKALOID AD Skopje;

• IMS documentation management and control;

• Monitoring, investigation and evaluation of deviations, incidents, out of specification results, complaints, quality defects, recall and return of the products from market;

• Management, follow up and evaluation of corrective actions and improvement actions;

• Risk management and evaluation;

• Change control management;

• Supplier assessment and qualification;

• Creation/revision of quality agreements, follow up of partner requirements and their implementation within all IMS processes;

• Personnel cGMP training, training regarding applicable standards, IMS and other quality relevant topics;

• Definition of the strategy, organization and implementation of validation activities for: Qualification and validation of premises, equipment, utilities, packaging validation, cleaning validation and validation of computerized systems;

• Definition of microbiological monitoring program, follow up and evaluation of results;

• Approval of master documentation, product specifications and standards for registration purposes;

• Check and issuance of production documentation, batch record review and retention for each product batch;

• Batch release (Qualified Person), creation of Certificates of compliance for each batch of medicinal product;

• Monitoring and creation of Product Quality Reviews;

• Monitoring, evaluation and improvement of environmental aspects.