Recently, the laboratories for physical-chemical analysis have been expanded, alongside with investing into new apparatus/instruments, in order to satisfy the great number and sophistication of activities imposed by the contemporary trends in pharmacy, regarding the regular control and inspection of the medicinal products, together with the scientific and research character of activities, as inevitable necessity for the Company progress.

Replek Farm Ltd. also invested in its contemporary and modern laboratory for microbiological quality control that is organized according to the current EU GMP standards.

For the successful functioning responsible is the team of young ambitions professionals, enthusiasts of more profiles, most of them with high education and additional specialization: masters of Science, specialists, doctoral students and PhDs who continuously improve their knowledge in the direction of integration into the new world trends in the field of pharmacy.

Quality control

Quality control

The Quality Control Department is a vital integral part of the global system for quality assurance of Replek Farm Ltd., that represents one functional integrity consisting of five Divisions, which include separate units, organized and equipped with instruments according to their activities, mainly in function of the Manufacturing Department, Research and Development Department, Department for Regulatory Affairs and the Commerce Department, that function as independent Departments on the Company level.
Recently, the laboratories for physical-chemical analysis have been expanded, alongside with investing into new apparatus/instruments, in order to satisfy the great number and sophistication of activities imposed by the contemporary trends in pharmacy, regarding the regular control and inspection of the medicinal products, together with the scientific and research character of activities, as inevitable necessity for the Company progress.

Replek Farm Ltd. also invested in its contemporary and modern laboratory for microbiological quality control that is organized according to the current EU GMP standards.

For the successful functioning responsible is the team of young ambitions professionals, enthusiasts of more profiles, most of them with high education and additional specialization: masters of Science, specialists, doctoral students and PhDs who continuously improve their knowledge in the direction of integration into the new world trends in the field of pharmacy.

The Quality Control Department is a vital integral part of the global system for quality assurance of Replek Farm Ltd., that represents one functional integrity consisting of five Divisions, which include separate units, organized and equipped with instruments according to their activities, mainly in function of the Manufacturing Department, Research and Development Department, Department for Regulatory Affairs and the Commerce Department, that function as independent Departments on the Company level.

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ACTIVITIES


The functioning of the Quality Control Department includes series of activities with main purpose to provide completely controlled, safe and standard quality on each final product of Replek Farm Ltd. according to the contemporary pharmacopoeia requirements in their latest editions, the current scientific knowledges and high international standards of this domain. The imperative of the working activities of this Department is the strict compliance with EU GMP norms and ISO standards, meaning complete evidence, monitoring, and recording of the processes at the Department level.

Division for Quality Control of the regular industrial production

directly responds to the requirements of the Manufacturing Department. It is divided into three units for continuous quality control of all feedstock; substances and packaging material and analytical control of all technological stages of intermediate to the final product into original packaging, of every manufactured batch. The department gives analytical support to the technological validations of the processes in the Manufacturing Department and “Cleaning” validations, in order to provide accurate, standard quality of each manufactured batch, adequate to the defined and approved Quality Specification, according to which the product is registered and free sold on the market in the Republic of Macedonia and abroad.

Division for Analytical development and research

performs activities in the function of the Research and Development Department and the Department for Regulatory Affairs. It is divided into: Unit for analytical development, Unit for validation of analytical methods, Unit for comparative tests and Unit for stability testing. This Division comprises development and creation of specifications of quality of pharmaceutical products in the stage of technological research projects, according to the contemporary pharmacopoeia requirements as well as other available professional and scientific literature and the data obtained by performance of comparative tests and studies versus reference and parallel products, present on the market in the Republic of Macedonia and wider. In this domain also belongs the development of the methodological procedures for quality control of the parameters of the specifications of quality and validation of analytical methods, to be further applied in the regular industrial control.

The received analytical results from the Unit for stability testing are foundation upon which is performed the optimal selection of quality and manufacturer of active ingredients and excipients, packaging material as type and quality, technological formulation and manufacturing procedure,  conditions of storage and shelf life of the products.

Division for Instrumental analysis

is in mutual function of these two departments, taking care for the selection, performance qualification, calibration, validation and maintenance of the laboratory equipment and instruments. It manages the contemporary sophisticated devices and instruments from renowned world manufacturers, all according to the highest quality standards from the field of the medicines’ quality control.

Division for Microbiological Quality Control

carries out microbiological control of the raw materials intended for pharmaceutical manufacture, also monitoring the manufacturing area, equipment and processes, with the final purpose to obtain adequate microbiological quality of the final products intended for commercial purposes.
It is completely equipped for the performance of manual routine microbiological investigation, as well as automatic quantification and identification of the microbiological growth.

Coordination Division

The complete extensive sequence of the described events that take place on a global level of the Quality Control Department is appropriately supported by the Coordination Division that is functioning in correspondence with the Standard Operative Procedures for each part of the activities, supported by adequate standard form records.


Thus conducted, all activities taking place in the Quality Control Department are focused on providing organization, transparency and traceability of the quality control aspects in total, in correspondence with the other Departments of Replek Farm Ltd., with the main objective – to provide controlled, standard high quality, safe and efficient product, according to the highest international standards and EU GMP norms.