About Us
Trepharm is pharmaceutical manufacturer of generics and brand medical product located in Kosovo, South East Europe. Trepharm is built in accordance with full EU cGMP guide- lines. Current Good Manufacturing Practice of the European Union and other Quality Standards have been applied and implemented during design, construction and commissioning of this manufacturing site. Based in South East Europe, Trepharm counts amongst largest pharmaceutical manufacturers in the region with presence in the Balkan region, EU and Middle East. Its workforce consists of young professionals committed to deliver high quality products and services based on clients’ needs and preferences. Trepharm remains dedicated in its constant search for professional excellence.
Mission & Vision
Trepharm is pharmaceutical manufacturer in Kosovo.
Mission
Our mission is to produce high quality affordable prices pharmaceutical products and manufacturing services for partners in the global market. Our vision is to make patients healthier through our pharmaceutical products. “Health for you” is our motto! We aim to produce pharmaceutical products that provide advanced solutions for our patient’s health. Each and every product of ours is engraved in excellence, quality and suitability based on patients needs and preferences.
Vision
Trepharm is led by set of values and principles whereas the most underlying principle is based on keeping health ( prevention) and acquiring health ( treating illness). Our company values and promotes patient centeredness in the whole process of pharmaceuticals manufacturing from designing products to producing and marketing them. We remain committed to be on the side of patients and their families by understanding their concerns, needs and preferences all along the process
Values
Trepharm is pharmaceutical manufacturer in Kosovo.
Inovation
Building standards which fulfil quality expectations will serve to increase industry demans Innovation in products, labels which preserve the environment and ethics, responsible marketing , all these are going to accompany in continuation “Trepharm” activity, besides putting all our capacities to the function of local scientific community
Reputation
Building the trust in a company is a hard and long battle, but we tend to prove that even a local company can be as successful, safe and trustful as much as the leaders in pharmaceutical field, to whom we are used to trust, are.
Motivation
The chalange in front of us is great, but greater is the will to show that we can!
Committing to a all-inclusive will, insures the engagement of “Trepharm” leadership to achieve a dream which proves the values this place hasPersonnel
Personnel of all levels are the essence of “Trepharm”. Their full commitment enables that their skills are developed in function of increasing the quality and safety of the products.
Efficacy
The road towards continuous enhancement is going to go through increasing technology levels, using the materials in efficient manner, minimizing the losses etc
Technology
Trepharm is pharmaceutical manufacturer in Kosovo.
- Each premises intended for production, processing, or storage of a pharmaceutical product is suitable in space, construction and positioning in order to facilitate cleaning, maintenance and to avaid the possibility of material mixing and cross contamination.
- Operations are performed in areas specifically designed and with proper size. Separate areas and control systems have been implemented for processing in order to prevent contamination or mixing during operations flow.
- Raw material, in process material and personnel entry routes are separated and do not cross with each other.
- Flooring, walls and ceilings are made from smooth surfaces easy to clean.
- There is a system for monitoring parameters of the work environment as temperature and humidity, this data is stored in BMS implemente by Kieback&Peter – Germany.
Water
Facility has two circulating types of water: sanitary and purified water. Sanitary water circulates only in service areas and is utilized for cleaning outside Clean Room. In the manufacturing areas Higly Purified water is utilized. Includes water, thus the HP Water is used only for cleaning of the manufacturing areas and equipment. The cGMP regulations have been taken in consideration during design and implementation. Water used in the facility complies to Ph. EUR and USP. Production Equipment All equipment used in production are GMP model (all contact parts and other outer surfaces are from stainless steel). Equipment is automated and have programmed in process quality control during production. Equipment have a high safety level for operators.
The water treatment system is the core of pharmaceutical production, as the generated water flows directly into the product or at least comes into contact with the product. Purified water complies with the requirements of European Pharmacopeia current edition in parameters of temperature, pH, conductivity, total organic carbon, lead, nitrates and microbiological analysis.
Monitorins system
There is a system for monitoring parameters of the work environment as temperature and humidity, this data is stored in BMS implemente by Kieback&Peter – Germany
Production
Buildings
The buildings have been designed and constructed in order to facilitate cleaning, maintenance, material and personnel movement.
Environment
Each premises intended for production, processing, or storage of a pharmaceutical product is suitable in space, construction and positioning in order to facilitate cleaning, maintenance and to avaid the possibility of material mixing and cross contamination.
Operations are performed in areas specifically designed and with proper size. Separate areas and control systems have been implemented for processing in order to prevent contamination or mixing during operations flow.
Raw material, in process material and personnel entry routes are separated and do not cross with each other.
Flooring, walls and ceilings are made from smooth surfaces easy to clean.
Floors
Floors are constructed with epokal cement, with epoxy final layer, same as in manufacturing areas. Only areas used by administration, archive and other non production areas have floors covered with tiles.
Electrical systems
Electrical systems are designed and installed in accordance to existing laws and regulations.
Lightning
All areas have suitable lighting. Lighting has been designed and installed by “GEA”, and it complies with EU, CE 73/23/EEC directive, amended with directive 93/68/EEC
Quality control
The quality management system of TrePharm is established, documented, applied and maintained referring to the current Good Manufacturing Practices Regulations in EU and other standards such as ISO 9001:2015, ISO 14001:2015 and ISO 17025:2018
Quality Control is part of GMP handling sampling, specifications and testing, as well as organizing documents, providing that necessary and appropriate tests are carried out and that materials, intermediates and products are not released for usage until their quality is ascertained to be satisfactory.
The Qualified Person, having the qualification and necessary expertise in accordance with Article 49 of Directive 2001/83/EC is responsible for releasing the medicinal products for the market. Qualified Person (QP) is responsible to ensure that each batch of medicinal product is manufactured and controlled according to the law, GMP and foreseen in Marketing Authorization (MA).
All suppliers of the raw and packing materials are qualified. The manufacturers and suppliers of goods and services that are relevant to quality are qualified under the responsibility of quality assurance with the involvement of the relevant affected departments with the aim of maintaining the quality stipulated in the specifications and contracts for products and services.
Regular product quality reviews (PQR) are carried out for all pharmaceuticals manufactured, tested and released.
Documentation system constitutes an essential part of the quality management system and is the key for TrePharm to operate in compliance with GMP requirements. Controls are implemented to ensure the accuracy, integrity, availability and legibility of the documents
All-in-One Solution
Air cleanliness, volumes, temperature, humidity and pressures are continuously monitored and recorded in all clean room areas as per cGMP requirements. Air cleanliness is class 100.000. All equipment have been designed and produced by “GEA Klimatechnik GmbH &Co. KG” – Austria. Heating is performed using gas and cooling using water through Chillers. All enforced measures exclude the possibility of air cross contamination. At the same time air is ricirculated and cleaned before it is ejected from the system in order to prevent environmental pollution.The air treatment is performed through HVAC units (AHU), where it is heated or cooled, humidified or dehumidified and filtered in supply through filters. The complete monitoring and controlling of air conditioning and ventilation is managed by BMS microprocessor-based controller system.
Temperature and humidity control is required for the raw materials, intermediates and finished products handled at the site. Specific storage conditions in the warehouse of raw materials/packing materials and finished products
A complete installation system includes: cover panels, wall panels, doors, pass boxes, windows, ceilings laminar ceilings and change parts for Clean Room. Clean Room installed systems comply with EN ISO 14644: Clean Room area
Quality assurance is a system of preventing failures which foresees nearly everything regarding safety of the products, quality standards and regulations. Exactly this system, takes measures to prevent defective product to reach advanced stages of distribution chain.
Quality management system in “Trepharm” is a combination of WHO directives, laws and regulations which guide the production of pharmaceutical products. This is not a rigid system, but a system in development and constant improvement, aiming fulfilment of our client needs in regards of safety, potency, quality, purity, uniformity, credibility and stability of the product.
Quality principles are in accordance with internal procedures used in planning, projecting and constructing the facilities, validation processes, analysis methods and systems.
All departments, as maintenance and engineering, production, quality control and quality assurance function in accordance with quality principles, SOP’s. These procedures are built based on GMP and built into internal structure and regulations of Trepharm.
Quality control laboratory is separate area adequate for the intention, constructed based on GLP standard. GLP principles have been developed in order to promote quality and validity of the data of analyzes, used to asses quality and safety of pharmaceutical products.
Quality Control Laboratory in “Trepharm” has been ideated as separate unit with sufficient space and assets for it to fully function as a control unit not only for “Trepharm” but aiming to become a referent laboratory for the region
Air cleanliness, volumes, temperature, humidity and pressures are continuously monitored and recorded in all clean room areas as per cGMP requirements. Air cleanliness is class 100.000. All equipment have been designed and produced by “GEA Klimatechnik GmbH &Co. KG” – Austria. Heating is performed using gas and cooling using water through Chillers. All enforced measures exclude the possibility of air cross contamination. At the same time air is ricirculated and cleaned before it is ejected from the system in order to prevent environmental pollution.The air treatment is performed through HVAC units (AHU), where it is heated or cooled, humidified or dehumidified and filtered in supply through filters. The complete monitoring and controlling of air conditioning and ventilation is managed by BMS microprocessor-based controller system
Facility has two circulating types of water: sanitary and purified water. Sanitary water circulates only in service areas and is utilized for cleaning outside Clean Room. In the manufacturing areas Higly Purified water is utilized. Includes water, thus the HP Water is used only for cleaning of the manufacturing areas and equipment. The cGMP regulations have been taken in consideration during design and implementation. Water used in the facility complies to Ph. EUR and USP. Production Equipment All equipment used in production are GMP model (all contact parts and other outer surfaces are from stainless steel). Equipment is automated and have programmed in process quality control during production. Equipment have a high safety level for operators.
The water treatment system is the core of pharmaceutical production, as the generated water flows directly into the product or at least comes into contact with the product. Purified water complies with the requirements of European Pharmacopeia current edition in parameters of temperature, pH, conductivity, total organic carbon, lead, nitrates and microbiological analysis
Temperature and humidity control is required for the raw materials, intermediates and finished products handled at the site. Specific storage conditions in the warehouse of raw materials/packing materials and finished products
There is a system for monitoring parameters of the work environment as temperature and humidity, this data is stored in BMS implemente by Kieback&Peter – Germany
A complete installation system includes: cover panels, wall panels, doors, pass boxes, windows, ceilings laminar ceilings and change parts for Clean Room. Clean Room installed systems comply with EN ISO 14644: Clean Room area
Buildings
The buildings have been designed and constructed in order to facilitate cleaning, maintenance, material and personnel movement.
Environment
Each premises intended for production, processing, or storage of a pharmaceutical product is suitable in space, construction and positioning in order to facilitate cleaning, maintenance and to avaid the possibility of material mixing and cross contamination.
Operations are performed in areas specifically designed and with proper size. Separate areas and control systems have been implemented for processing in order to prevent contamination or mixing during operations flow.
Raw material, in process material and personnel entry routes are separated and do not cross with each other.
Flooring, walls and ceilings are made from smooth surfaces easy to clean.
Floors
Floors are constructed with epokal cement, with epoxy final layer, same as in manufacturing areas. Only areas used by administration, archive and other non production areas have floors covered with tiles.
Electrical systems
Electrical systems are designed and installed in accordance to existing laws and regulations.
Lightning
All areas have suitable lighting. Lighting has been designed and installed by "GEA", and it complies with EU, CE 73/23/EEC directive, amended with directive 93/68/EEC
Quality assurance is a system of preventing failures which foresees nearly everything regarding safety of the products, quality standards and regulations. Exactly this system, takes measures to prevent defective product to reach advanced stages of distribution chain.
Quality management system in “Trepharm” is a combination of WHO directives, laws and regulations which guide the production of pharmaceutical products. This is not a rigid system, but a system in development and constant improvement, aiming fulfilment of our client needs in regards of safety, potency, quality, purity, uniformity, credibility and stability of the product.
Quality principles are in accordance with internal procedures used in planning, projecting and constructing the facilities, validation processes, analysis methods and systems.
All departments, as maintenance and engineering, production, quality control and quality assurance function in accordance with quality principles, SOP’s. These procedures are built based on GMP and built into internal structure and regulations of Trepharm.
Quality control laboratory is separate area adequate for the intention, constructed based on GLP standard. GLP principles have been developed in order to promote quality and validity of the data of analyzes, used to asses quality and safety of pharmaceutical products.
Quality Control Laboratory in “Trepharm” has been ideated as separate unit with sufficient space and assets for it to fully function as a control unit not only for “Trepharm” but aiming to become a referent laboratory for the region
The quality management system of TrePharm is established, documented, applied and maintained referring to the current Good Manufacturing Practices Regulations in EU and other standards such as ISO 9001:2015, ISO 14001:2015 and ISO 17025:2018
Quality Control is part of GMP handling sampling, specifications and testing, as well as organizing documents, providing that necessary and appropriate tests are carried out and that materials, intermediates and products are not released for usage until their quality is ascertained to be satisfactory.
The Qualified Person, having the qualification and necessary expertise in accordance with Article 49 of Directive 2001/83/EC is responsible for releasing the medicinal products for the market. Qualified Person (QP) is responsible to ensure that each batch of medicinal product is manufactured and controlled according to the law, GMP and foreseen in Marketing Authorization (MA).
All suppliers of the raw and packing materials are qualified. The manufacturers and suppliers of goods and services that are relevant to quality are qualified under the responsibility of quality assurance with the involvement of the relevant affected departments with the aim of maintaining the quality stipulated in the specifications and contracts for products and services.
Regular product quality reviews (PQR) are carried out for all pharmaceuticals manufactured, tested and released.
Documentation system constitutes an essential part of the quality management system and is the key for TrePharm to operate in compliance with GMP requirements. Controls are implemented to ensure the accuracy, integrity, availability and legibility of the documents
Meet with our professional team
Dr. Syed E. Abidi
Managing Director
Mergim Prishtina
Managing Director
Dr. Shahid Raza
Chief Operating Officer
Saeed Humza
Technical Advisor
Fitore Zogu
QA & QC Manager
Liridona Isufi
R&D Manager
Admir Mujovi
Regulatory Affairs Manager
Dukagjin Gashi
Production Manager
Alban Mehmeti
Engineering Manager
Fortesa Zogu
Supply Chain Manager
Leonora Prenaj
Senior Manager Finance
Ahmet Hoxha
Qualified Person Pharmacovigilance QA & QC Advisor