BIOGAIA SUSTAINABILITY REPORT 2021 15 Materiality and risks To create consumer confidence and to give consumers a good experience of using BioGaia’s products, it is critical that the products are safe and meet both quality demands and other expectations. The risk that the products do not meet statutory requirements for food supplements, contain objectionable contaminants or do not comply with BioGaia’s own quality standards is actively minimised. Quality is one key aspect throughout the value chain. From ensuring that research on product benefits is reliable and there is a consistent production process, to the product maintaining its high quality after delivery to the customer. Therefore, BioGaia applies significant direct control of product quality in the production phase, and more indirect control once the finished product has been sold to distributors and then later sold at resellers’ outlets. When BioGaia sells the products through its own e-commerce, BioGaia has direct control of the product quality all the way to the end consumer. How work is conducted BioGaia’s own Quality Management System defines the company’s way of working to ensure the safety and quality of the products and is described in the BioGaia Quality Manual. This includes ensuring high-quality clinical studies, quality assurance of systems and daily activities, as well as building quality aspects into product development and production processes. The guidelines also apply to activities and purchasing that are outsourced to subcontractors. BioGaia’s Quality Standard (BQS) is a component within the Quality Management System and defines the requirements the products must comply with. These include, for example, requirements in applicable laws and regulations related to safety and quality of food supple- ments, customer demands, raw material requirements and manufacturing standards, as well as scientific and technical requirements. Within the scope of the BioGaia Quality Standard, the company also applies the systematic preventive approach to food safety known as HACCP (Hazard Analysis and Critical Control Points) in which the production processes are analysed with respect to biological, chemical and physical hazards that may cause the product to be unsafe, and control measures are taken to reduce these risks to a safe level. Production controls and related activities, at contract manufacturers as well as in our own production unit, BioGaia Production, take place according to standardised processes and routines and by personnel with relevant training in quality and product safety. BioGaia checks every single batch that is produced against the applicable requirements and determines whether it is fit for intended use. When applicable, precautionary testing for aspects impacting the quality and safety is carried out. For example, such testing can include, but is not necessarily limited to, verification that the products contain the specifiedquantities of probiotic bacteria and are not contaminated with objectionable contaminants. The testing is either performed by qualified third parties or by BioGaia’s in-house laboratories. Non-conformances are managed and investigated using stan- dardised methodology to ensure that only products deemed safe are released to the market. The investigation involves determining the cause of the problem and identifying measures to prevent the reoccurrence of similar problems. BioGaia monitors contract manufacturers’ compliance with the applicable quality requirements through documented reviews and periodic audits, where any identified non-confor- mances, complaints and quality issues are reviewed and acted upon as appropriate. These audits also ensure that any action plans are satisfactorily developed and implemented as necessary. The focus is on preventive measures as well as verifying that appropriate training is performed. Technology and knowledge transfer are conducted in a defined manner as required for a new or modified product, process or methodology. BioGaia Production and BioGaia’s contracted manufac- turers are authorised to manufacture food and are certified according to the appropriate standards for good manufac- turing practice for the product in scope, such as ISO 22000, US FDA 21 CFR Part 111 and/or GMP for medicines. BioGaia has never needed to recall products already distributed to consumers. Progress and priorities going forward The improvements carried out in 2020, that enabled BioGaia to ensure that the majority of the Protectis portfolio meets the requirements for labelling of free from lactose, milk and gluten according to requirements in EU regulations, were extended to additional product families in 2021. In 2021, optimisations in the supply chain were made, which resulted in a reduction in transportation while retaining quality. The quality standard and its tools were updated with regard to clearer requirements on products and suppliers, which streamlines quality assurance work in the product develop- ment process. Further digitalisation of the Quality Manage- ment System, with the introduction of electronic signatures for all quality documents, reduced paper use and enhanced the efficiency of work processes. Priority elements in the further development of the Quality Management System will be implemented in 2022. Product quality and product safety (GRI 3-3) Number of product withdrawals due to inadequate product safety (BSD 3) 2021 2020 2019 Number of recalls1) 0 0 0 1) Definition: Withdrawals of products from customers due to product safety issues Healthy products CONTENTS
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