Type of manufacturing process

The activity of Replek Farm Ltd. Skopje consists of:

1. Manufacture of non-sterile medicinal products for human use
- Solid dosage forms (tablets, coated tablets, film coated tablets, hard gellatine capsules)
- Liquid and semi solid dosage forms (syrups,solutions, suspensions, cremes, ointments, gels, lotions, sprays, suppositories, vagitories)

2. Only packaging of medicinal products for use at human medicine
- Sterile products (parentheral preparations with small volume, eye drops)
-Non sterile products( solid dosage forms, liquid dosage forms)

Manufacturing of the medicinal products is made on the existing equipment, without the use of strictly intended equipment of certain product.

During the manufacturing process toxic materials are neither used nor manufactured.

Manufacture

Производство

Реплек Фарм ДООЕЛ Скопје е генеричка фабрика, чие производство започна во 2002 година во
соработка со реномирани фармацевтски компании.
Со ангажираниот стручен тим и инсталираната опрема може да произведуваме:
цврсти, течни и полуцврсти фармацевтски дозажни форми.
Производните простории на Реплекфарм се дизајнирани и опремени согласно современите GMP барања за фармацевтско производство на лекови за хумана употреба. РЕПЛЕКФАРМ располага со опрема од најреномираните европски производители, како: Glatt, IMA, Uhlmann, CAM и др
Согласно GMP барањата поставени се автоматски HVAC системи од најеминентни проиводители, како што се Bluebox, Aermec, Luwa и др.
Со помош на централен DDC систем за автоматско управување, се прави контрола и мониторинг на амбиенталните услови (диференцијални притисоци, температурата и влагата во производните простории и магацините).
Производството на РЕПЛЕКФАРМ ДООЕЛ Скопје функционира како кампањско производство односно постои сепарација по време во производството, со валидирани процеси на чистење и контрола на амбиенталните услови, со цел спречување на cross контаминација согласно барањата на GMP имплементирани преку водичите на FDA, EMEA, Светска здравствена организација, PIC/S.
Денес, како резултат на ангажирање на сопствен развој
и истражување, Реплек Фарм произведува околу
150 различни лека во повеќе од 170 различни
фармацевтски формии јачини.

Manufacture

The manufacturing process at Replek Farm Ltd.Skopje is made according to the clearly defined procedures prescribed with the Good Manufacturing Practice standards, in order to receive a product that in its specified shelf life complies with its assignation, and satisfies the specification requirements according to which it has been registered.

Type of manufacturing process

The activity of Replek Farm Ltd. Skopje consists of:

1. Manufacture of non-sterile medicinal products for human use
- Solid dosage forms (tablets, coated tablets, film coated tablets, hard gellatine capsules)
- Liquid and semi solid dosage forms (syrups,solutions, suspensions, cremes, ointments, gels, lotions, sprays, suppositories, vagitories)

2. Only packaging of medicinal products for use at human medicine
- Sterile products (parentheral preparations with small volume, eye drops)
-Non sterile products( solid dosage forms, liquid dosage forms)

Manufacturing of the medicinal products is made on the existing equipment, without the use of strictly intended equipment of certain product.

During the manufacturing process toxic materials are neither used nor manufactured.

The manufacturing process at Replek Farm Ltd.Skopje is made according to the clearly defined procedures prescribed with the Good Manufacturing Practice standards, in order to receive a product that in its specified shelf life complies with its assignation, and satisfies the specification requirements according to which it has been registered.

Slider

The factory for manufacturing medicinal products, its manufacturing zone is located in the basement of the building A with a space of 3.522 m2.It is designed by the company specialised into pharmaceutical and industrial design.

The project was completed in 2000, made according to the cGMP for manufacturing medicinal products and approved by the Ministry of Health of the Republic of Macedonia.The manufacturing facility is completed and put into work in April 2002.

The Warehouse for raw materials and packaging materials and the Warehouse for finished medicinal products are over the total surface of the Manufacturing facility.

The deliver of the  raw materials, packaging material and finished product between the warehouse and the facility is made through two elevators.

All neccesary installations for the air conditioning, power supply, fluids (water, demineralized water, steam, air) are located in the space between the floor of the warehouse and the sunken ceiling of the manufacturing facility.

The functional  space organization provides separate entrances and directions of moving the personnel and raw materials in order to achieve conditions for safe and quality manufacture.

The rooms layout is in accordance with the stages manufacturing order.


The manufacturing facility consists of two wholes :

Working space

–     The rooms for manufacture of solid dosage forms : tablets, film coated tablets and capsules (Department for solid dosage forms)

–    Rooms for manufacturing semi-solid and liquid dosage forms and their mpackaging into primary packaging (Department for semi-solid and liquid dosage forms)

–    Rooms for packaging process of solid dosage forms into primary packaging and secondary packaging of the products (Confectioning Department).

Ancilliary space

The ancilliary space consists of tampon zones, wardrobes, toilettes, restaurant for the employees  of the manufacturing division, ancilliary warehouses, offices, technical rooms and rooms of the control laboratory.


HVAC system (Heating, Ventilation, Air Conditioning)

The complete construction and qualification of HVAC system is according to the EU GMP recommendations and standards ISO 14 644 that provides fulfillment of its three basic roles : protection of the product from contamination, protection of the employees( by providing comfort working conditions) and environmental protection from the manufacturing processes.

The quality of the air is classified as Class D EU GMP (ISO 8) and ISO 9 into the secondary packaging zone.

HVAC factory system is divided into three sections such as :

System A and System B

Line1 and Line 2

Line K1 and Line K2