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

Epax phase-3 study builds base for continued expansion into pharmaceutical omega-3 segment

Epax AS continues expansion into the pharmaceutical omega-3 segment with study
on AKR963 successfully achieving phase 3 study efficacy endpoints.

Read Press Release

 
 

EPAX Announces Corporate Restructuring

The Omega-3 lipids corporation previously formed by Trygg Pharma and former EPAX AS will be named EPAX AS. Former EPAX AS will become Epax Norway AS, a fully owned subsidiary and the key operating company of the Epax group.

Read press release

 
 

EPAX again honored as top supplier by Banner Pharmacaps.

EPAX AS was recognized for on-time deliveries and high quality standards.

Read press release

 
 
EPAX AS
PO Box 2047
NO-6028 Aalesund, Norway

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Fax: +47 70 13 59 61
E-mail: epax@epax.com
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