Quality Assurance

To ensure consistent quality of all EPAX products, we:

  • Conduct internal quality audits to ensure compliance with cGMP (current Good Manufacturing Practice) for API (Active Pharmaceutical Ingredients) and the authorities' regulations for the production of marine-based Omega-3
  • Evaluate critical raw material suppliers
  • Handle and process products under a competent HACCP system in accordance with the US FDA’s seafood HACCP regulation 21 CFR 123 and Norwegian and European authorities. This includes full quality control and assurance
  • Maintain written product specifications, material safety data sheets (MSDS) and production records
  • Maintain standard operating procedures
  • Have implemented detailed customer feedback, non-conformity and change control, and Continuous Control schemes with Corrective Action Programmes
  • Ensure that batch records are reviewed by authorized personnel prior to release
  • Maintain traceability records of each EPAX product manufactured at our facility

 
 

Quality Control

In addition to quality assurance processes, at EPAX we:

  • Maintain compliance with industry standards established under the Omega-3 monographs in the EU Pharmacopoeia and GOED Omega-3 Voluntary Monograph
  • Impose strict limits on our organization; our goal is to stay ahead of regulatory developments, continually setting new standards in the industry
  • Perform multilevel testing: all products are subject to stringent internal specification testing, from the applied raw material to our finished products
  • Perform ongoing stability studies to determine the shelf life of every product
  • Issue Certificates of Analysis – based on confirmation of quality and compliance – for each of our products
  • Undertake validation of analytical methods
 
 
EPAX News & Events

Trygg Pharma AS has acquired 100 percent of the shares in EPAX AS

AALESUND, Norway (Sept. 03, 2010) — Trygg Pharma AS, a company jointly owned by Aker BioMarine ASA, a Norwegian biotechnology company, and Lindsay Goldberg, a New York-based investment fund, has acquired 100 percent of the shares in EPAX AS from Austevoll Seafood ASA. EPAX AS is a world-leading supplier of concentrated, marine-derived omega-3 formulas that target specific health conditions.

Read press release



 
 

Epax Unveils Latest Study At Issfal 2010

Leading Omega-3 supplier, EPAX AS, will present results from studies related to the treatment and prevention of metabolic syndrome and Type 2 Diabetes at the ISSFAL1 conference which runs from 29th May – 2nd June in Maastricht, Netherlands.

Read press release

 
 

EPAX invites you to explore our enviromental stewardship policy


www.epax.com/ecovision

 
 
EPAX AS
PO Box 2047
NO-6028 Aalesund, Norway

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