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

Press Release 27 June 2008

EPAX AS recnognised as a 2007 top supplier by Banner Pharmacaps, INC.

 
 

Facts about EPAX

Raw material, quality control, production and product.

English and Norwegian versions.

 
 

Purity Beyond Measure

EPAX' American launch of expanded purity concept a success
More ::
 
EPAX AS
PO Box 2047
NO-6028 Aalesund, Norway

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Tlf: +47 70 13 59 60
Fax: +47 70 13 59 61
E-mail: epax@epax.com