Quality
 

 

LiveLong Omega3is produced at a manufacturing plant approved for GMP production (Good Manufacturing Practice), and carries a grant for the manufacturing of APIs (Active Pharmaceutical Ingredients) and maintains an approved HACCP system.

The LongLive Omega3 oil is made of high-quality raw materials. State-of-the-art manufacturing techniques, including enzymatic production, ensure that the oils are subjected to mild treatment during processing.

High quality manufacturing ensures product quality with respect to vital parameters such as purity, concentration levels, oxidation, colour, taste and smell. Every production run carries full quality control documentation.

 

Quality Assurance in EPAX production

 

To ensure consistent quality of all EPAX products, Epax:

  • 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 Purity Statement

EPAX' omega-3 concentrates well below strictest international purity standard for environmental pollutants

 

 

Facts about EPAX

Raw material, quality control, production and product.

English and Norwegian versions.

 

 

 

 

 

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