Product quality and product safety

The BioGaia Quality Standard is the name of a list of demands that BioGaia makes to maintain high quality and safety related to the products. The requirements include how both BioGaia and suppliers shall relate to laws, regulations, customer demands, raw material requirements and manufacturing standards.

Manufacturing is carried out according to good manufacturing practice, that is using standardized processes and routines, and by employees with relevant training in quality and product safety. BioGaia checks every single batch that is produced against the requirements specification and the analysis methods are quality assured.

BioGaia measures how well suppliers comply with quality requirements and follows these up with regular inspections and evaluation meetings where any nonconformances, complaints and quality issues are reviewed. These also ensure that any action plans are satisfactory. The focus is on preventive measures.

Thanks to high quality requirements, BioGaia has never needed to recall deliveries from the market and there are very few complaints.

Product development from an environmental and ethical perspective

In addition to maintaining high product quality and safety, BioGaia’s product development strives to improve the products from an environmental and ethical perspective. Demands and expectations from consumers drive development towards purer products, for example regarding the number of ingredients, and from demands for ecological, gluten-free and vegan alternatives.

The use of palm oil is a prioritized example. BioGaia’s probiotics contain live bacteria which require a controlled environment to retain their effect. The special properties of palm oil mean that it is added to the products. Although BioGaia’s use is extremely limited, the production of palm oil has a significant environmental impact globally and creates an ethical dilemma. Development work is therefore ongoing to completely phase out palm oil within five years, in a way that does not risk the quality of the products. BioGaia only purchases palm oil from suppliers that are members of the Roundtable for Sustainable Palm Oil (RSPO).

Ethics and safety in clinical trials

BioGaia works with a network of prominent and independent researchers who study the effects and safety of BioGaia’s products. In order to ensure transparency and aim for the highest possible scientific standards, BioGaia encourages researchers to design studies and report results in a way that enables publication in wellrenowned medical journals. The aim is that all studies, regardless of result, should be published. Furthermore, BioGaia requires all studies to be ethically approved and registered on a public website, such as ClinicalTrials.gov.

Important issues

  • Product quality and product safety
  • Ethics and safety in clinical trials

Targets and results

  • Product recalls. Thanks to high quality requirements, BioGaia has never needed to recall deliveries from the market and there are very few complaints.
  • Palm oil free by 2023. The aim is to launch palm oil free tablets during 2019. Development work continues with other products and the aim is to completely phase out palm oil in all BioGaia’s products in all markets by 2023.
  • Reviewed and published studies. Studies should as far as possible be published. To date 203 clinical studies have been carried out. Results have been published in 180 articles (February 2019).