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Facilities
One Pharma’s plant, in operation since 1996, is located in Sximatari (Viotia) covering a production area of 3.500 m2 in a total area of 15.000 m2.
The National Organization for Medicines (EOF) conducts audits to One Pharma according to European standards (PIC/S) concerning the Manufacture, Packaging, Quality Control and Storage. Moreover, audits are periodically conducted by clients and certification bodies.
All manufacturing processes are in accordance with eu-GMP and ISO 9001:2008 standards.
One Pharma’s modern manufacturing facilities have been regularly renovated (latest renovation in 2007) and they comply with the GMP standards. The facilities are equipped with modern systems in order to keep every manufacturing and storage area under controlled steady-state conditions (temperature, humidity, differential pressure).
We renew regularly our manufacturing equipment with new machinery of high quality imported by reliable firms, fully automated, complying with GMP requirements.
The production capacity of the plant has increased significantly during the last few years by continuous investment in new machinery, having a capacity of big annual volumes such as 900 million tablets, 300 million capsules, 36 million of oral solution bottles,30 million of nasal sprays, 10 million of external solutions (low and high volume bottles).
The staff is fully trained and participates in regular GMP training programs, in order to keep the quality of the production unit in high levels.
One Pharma has an IN PROCESS CONTROL laboratory into the manufacturing area in order to assure the best quality of the products and it applies SPC (Statistic Process Control) systems in all critical manufacturing phases.
One Pharma’s manufacturing activities range in a broad spectrum of pharmaceutical products, such as:
NON STERILE PRODUCTS – MANUFACTURE AND PACKAGING
| FORMS | CATEGORIES | MANUFACTURING METHODS | PACKAGING |
|---|---|---|---|
| TABLETS |
Simple coated Sugar-coated Slow-release |
Wet granulation Dry mixing Aqueous and organic coating Suspensions production Liquid solutions production |
PVC Blisters ALU-ALU Blisters PE Bottles Sachets Glass bottles |
| CAPSULES |
Simple Antibiotics Slow-release pellets |
||
| NASAL |
Solutions
Suspensions Sprays Inhalers |
||
| NASAL HORMONAL |
Solutions Suspensions Sprays Inhalers |
||
| LIQUIDS FOR INTERNAL USE |
Syrups Suspensions Oral solutions Emulsions Elixirs Antacids Oral solutions in sachets |
||
| LIQUIDS FOR EXTERNAL USE | Solutions | ||
| POWDERS FOR INTERNAL USE |
Simple Dry syrups Powders in sachets |
PRIMARY PACKAGING
| FORMS | CATEGORIES |
|---|---|
| SOFT CAPSULES |
Alu-alu blister
Bottles |
SECONDARY PACKAGING
| FORMS | CATEGORIES | MANUFACTURING METHODS | PACKAGING |
|---|---|---|---|
| Opthalmic solutions in monodose pipetten and flacons | Solutions for external use | Sterile products | Creams |
| Ointments | Gels | Packaging for cytostatic drugs |
Quality Control
One Pharma has fully equipped Quality Control Laboratory which carries out chemical and microbiological analysis. It utilizes state-of-the-art instruments (HPLC, GC, Dissolution Tester etc.) with validated software.
It is staffed with experienced scientists, many of those disposing of master degrees. They are trained in a constant basis participating in high level seminars.
We perform controls of the starting materials (active substances and excipients), semi-finished and finished imported products, packaging materials, as well as in every stage of the manufacturing process.
We assess our analytical methods according to the current guidelines of the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use).
We also perform stability studies (pre-approval, post-approval, on-going stability) under controlled conditions 25oC/60% RH, 30oC/60% RH, 40oC/75% RH.
The Microbiological Laboratory is staffed with skilled biologists who perform the analysis according to the requirements of the European Pharmacopoeia.
