With huge investments made in state-of-the-art facilities and professional staff, one Portuguese company is well on its way to achieving its goal of providing high-quality services to the pharmaceutical industry.
FARMA-APS Group has been active in the Portuguese market for 25 years. It is currently the country's third largest pharmaceutical company and the leader in generics with 134 molecules on the market all supported by EU CTD registration files.
In April 2006, FARMA-APS opened its world-class manufacturing unit, designed beyond current GMP guidelines, for producing oral solid dosage forms at a capacity of 65 million packs a year.
Hygiene is crucial when producing drugs and this facility is supported by a state-of-the-art HVAC system that guarantees isolation, contamination control and totally flexible environmental conditions. Cross contamination between different products under process is avoided as well as any crossover between clean and dirty utilities.
This new facility is equipped with the latest appliances and technology. From the earliest stage, the product is transported in sealed containers. This isolation is complemented by the use of an in-vacuum and gravity feeding system, guaranteeing total safety and avoiding cross-contamination. This means that quality is maintained and a higher turnover is generated.
Two Tablet Pressing Rooms generate an output of 350,000 tablets per hour. Both rooms can perform indirect weight control with force monitoring systems for main and pre-compression. Tablets can range up to a diameter of 25mm.
In the Coating Room, equipment is designed to sugar and film coat tablets. This equipment has its own validatable CIP system.
The Capsule Filing Room has a capacity of 40,000 capsules per hour. Capsules can be filled with powder, pellets or tablets. There is also an IPC for weight control and a capsule dedusting unit.
The three packaging lines generate a total capacity of 600 blisters per minute. Each line has all the necessary systems to detect product absence and to control bar-code readings on the package and leaflet. In-line aluminium and Code 39 printing are also available. One of the lines is equipped with a dehumidifying system, allowing relative humidity levels of less than 30 per cent at 19°C to be reached.
FARMA-APS can blister in PVC/ALU, PVC/PVDC/ALU, ALU/ALU, PP/ALU, PVC/ACLAR/ALU and PVC/ACLAR/PVC/ALU.
The whole process is closely monitored by a quality control system, with completely new facilities and equipment for all types of pharmaceutical needs, and uses the latest test techniques.
FARMA-APS wants to reach the highest levels of quality assurance in development, production and control of the medicines through a Plan-Do-Check-Act documented methodology. Its effectiveness is assessed from the perspective of ongoing improvement.
The company's vision and ambition is evident and its aim is to focus on high quality standards and sustained growth. It has invested in a Galenic laboratory that is fitted out with a 10 per cent scale replica of the production equipment, it has qualified employees; top quality facilities suitable for developing its own products; and the ability to boost the technology transfer process.
The excellent services offered, the flexibility, as well as an accurate perception of needs and innovation all make FARMA-APS a solid company that has the capacity to answer its clients needs on time and with 100 per cent professionalism.