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Facilities

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

SOFT CAPSULES

  • ALU-ALU blisters
  • Bottles

 

 

SECONDARY PACKAGING

Opthalmic solutions in monodose pipetten and flacons

Solutions for external use

Sterile products

Creams

Ointments

Gels

Packaging for cytostatic drugs
(sticking of authenticity tape)

 

 

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 (25°C/60% RH, 30°C/60% RH, 40°C/75% RH). The Microbiological Laboratory is staffed with skilled biologists who perform the analysis according to the requirements of the European Pharmacopoeia.