'OQP'

Our Quality Promise

Apr 8, 2022

Our Quality Promise

At Wellma, quality and regulatory compliance is at the heart of everything we do. We are a Swedish-founded group with a presence across Europe aiming to become the leading development and co-manufacturing partner to B2C-actors in the nutraceutical and pharmaceutical space worldwide. We aim to help our customers grow and succeed with their visions by supplying innovative, safe, and high-quality products. In light of this, we expect perfection when it comes to the quality of products delivered by Wellma, and it is our firm belief that this is essential to ensure long-term success. Therefore, we have set up a group-wide quality standard for Wellma, to ensure the quality of every single one of Wellma’s customers product. We call it Our Quality Promise.

Our Promise

Our Quality Promise is our promise to our customers, and its foundation is the expectations and requirements we set for all sites developing and producing products for Wellma, as well as for the suppliers to the group.

To ensure the quality of our customers´ final products, we expect all sites producing or developing for Wellma´s customers to have obtained respected certifications to ensure their regulatory compliance and processes. We set the bar high, and therefore we have instilled the following requirements across our group:

All sites producing or developing for Wellma’s customers should hold at least one of the following certifications:

o  FSSC 22000 (Food Safety Management Systems)

o  IFS Food (International Featured Standard) with relevant subcategory

o  BRC / BRCGS (British Retail Consortium)

o  Note: Other related certifications recognised by the GFSI (Global Food Safety Initiative) to be assessed on a case-by-case basis

All sites producing or developing pharmaceuticals should in addition also be cGMP certified.

To ensure the quality of the material used in our development and production activities, Wellma has developed and implemented processes to ensure the quality of all suppliers and materials utilised at our sites.

By this, our aim is to ensure our customers, and in turn their customers, that all products from Wellma is in line with specifications and agreed quality, as well as being transparent with Wellma´s expectations on our sites and suppliers.

What we do to ensure our promise

All production sites developing or producing for Wellma are asked to share their up-do-date certifications before producing for Wellma. If an existing site does not have the required certifications, the site will be required to prepare a detailed plan outlining the changes to be made to obtain the required certifications, along with an appropriate timeline. Wellma´s quality leads will offer support if needed. Until these certifications are then received, Wellma´s quality leads will closely monitor the sites and compliance and perform an audit on the site annually to ensure its quality. All sites, own or partner sites, will be audited annually to ensure the Wellma quality promise.

An audit performed by Wellma will cover certifications & licenses, organizational structure & personnel, facility, equipment, lab controls, reagent & solution labelling and qualification, sample shipment receipt & storage, supplier audit, internal communication & training, and data-handling procedures (along with record & report retention). The result of Wellma's internal (as well as external) audit is available on request for customers.

At our production and development sites, we set high expectations on the people; only skilled and trained operators can work within the group and handle our customers' products.

To ensure the quality of materials across Wellma, we conduct onsite or written desk audits of all suppliers on a consistent basis (at least once every three years). These efforts will help guarantee the quality of all materials that Wellma comes into contact with.

In the case of deviation, customer feedback or a complaint, we have a Corrective and Preventive Action (CAPA) system in place, to improve our processes to eliminate causes of any undesirable situations, and by that avoiding that it will happen again.

Our Expectations

In order to protect our customers, we expect all individuals working with or for Wellma to know about Our Quality Promise and commit to following its principles. We intend for all managers at Wellma to actively discuss the Quality Promise with employees on an ongoing basis, and ensure that it is easily accessible at all Wellma workplaces. We encourage an active dialogue surrounding Our Quality Promise, and expect all team members to feel involved in the iteration process.

We always have time to talk through Our Quality Promise with our customers and our suppliers to assist in our collaboration efforts with our partners and to help us reach our goals. We have the highest expectation for ourselves and our partners, and with the standards we have set (both internally and externally) we will be able to fully stand by the quality and integrity of Wellma’s customers´ products.

As a customer to Wellma, this is Our Quality Promise to you. Please let me know personally if you have any questions around Wellma's products and food safety culture, because this is a top priority to us.


Christian Merup
CEO at Wellma

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