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Quality

Quality – One of the Four Key Values of Hemofarm

Producing quality, safe and effective medicines is the backbone of Hemofarm’s strategy and a reflection of its determination to establish, maintain and continuously upgrade its quality management system. The goal of quality assurance is to obtain safe pharmaceutical products of the required and uniform quality through the company’s processes, from starting material purchasing, through production, to final control, storage and distribution onto the market.

In this way we realise in practice the motto: quality cannot be controlled inside a product, but it rather must be integrated into it.

The activities of Hemofarm Quality are closely connected with those of other organizational units such as Production, Research and Development, and Purchasing. All quality assurance and control system procedures comply with the Good Manufacturing Practice (EU GMP1) requirements, compendial regulations and other relevant international standards. The EU GMP principles are applied to the entire cycle of origination and shelf life of each product in Hemofarm.

The laboratories (chemical, microbiological and laboratory for quality control of packaging material) are equipped with state-of-the-art equipment for testing raw material, packaging material and finished products (sterile and non-sterile) in accordance with the requirements of Good Manufacturing Practice, compendial regulations and ICH (International Conference of Harmonisation).

Hemofarm Quality is an organizational unit established at the end of 2014 by pooling the Quality Control and Quality Assurance divisions. Organizational efficacy was improved, duties were segregated more precisely and the construction of a new Quality building (‘greenfield’ project), covering a total surface area of 7,000 , was approved.

Example 61 – External audits conducted in 2014:

17

outsourced processes

2

manufacturers of finished or semi-finished products

27

manufacturers of packaging material

9

manufacturers of active ingredients

3

manufacturers of consumables

3

other

Improvement of Quality Control Processes

Hemofarm continuously and intensively works on the improvement of quality in all segments of its operation.

A proactive approach is applied – the rules which regulate operations in the field of the pharmaceutical industry are monitored, regular internal audits are conducted and the available results of regulatory audits conducted outside Hemofarm are monitored on a regular basis through a system of continuous quality improvement. The goal is to maintain the highest level of quality of Hemofarm’s products and compliance with regulations and standard practices in the pharmaceutical industry through preventive actions.

The compliance with Good Manufacturing Practice requirements and ISO2 9001:2015, ISO 14001:2004 and OHSAS 18001:2007 standards was confirmed by audit findings in 2014.

  • German Inspectorate for Medicinal Products of the Darmstadt Region – production of solid dosage forms in Podgorica

  • State Administration for Medicinal Products of Ukraine – production of liquid dosage forms in Podgorica, production of solid dosage forms and injection solutions in Vršac, production of solid dosage forms in Šabac

  • Medicines and Medical Devices Agency of Montenegro (CALIMS) – production of liquid dosage forms in Podgorica

Complaints

Complaints are usually received directly – by phone, regular mail or e-mail. Detailed procedures, which refer to complaints about products, are established in Hemofarm.
Upon each complaint received, and following the necessary investigation of the complaint, Quality Control informs the complaining party about the results of investigation.

All adverse reactions to a medicinal product, as well as production-technical related complaints, are reported to the Medicines andMedical Devices Agency of Serbia (ALIMS) and are available on its official website.

Guarantee of Quality

Hemofarm observes and implements all legal regulations of the Republic of Serbia; international regulations, standards and guidelines which regulate the areas of development, registration, production and sales of medicines and medical devices, as well as the requirements and provisions of all contracts with local and international partners.

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1 Good Manufacturing Practice – performance of production and testing in a way which enables providing adequate product quality.

2 ISO – International Organization for Standardization.