Our approach to supply chain management
As a business which outsources all its manufacturing activities, we have an obligation to maintain adequate oversight of our end-to-end supply operations and to be aware of any associated environmental health and safety, business ethics and supply chain security risks which may exist within our supply chain, including risks to our supply chain arising from the effects of climate change, so these can be effectively managed.
To support those aspects of our supply chain which we are directly involved with:
- in the UK, we hold Wholesale Dealers Authorisations, assessed, and approved by the MHRA to allow wholesale dealing of medicines in the UK
- in France we hold Exploitant status and a Wholesale Dealers Authorisation, assessed and approved by ANSM, to allow the marketing and wholesale dealing of medicines in France.
Both our UK and Italian trading companies hold ISO 13485:2016 (similar to ISO 9001) assessed quality systems to support the marketing of medical devices, which are independently assessed by BSI (UK) and TUV (Italy). Both of these entities also have CE marked medical devices, Class II and above, independently assessed by the
Italian and UK Ministry of Health assigned Notified Bodies. In the UK, we are audited regularly by Trading Standards to support the placing on the market of products designated as food supplements.
In China, we are working towards having an NMPA accredited quality management system to enable us to hold Marketing Authorisations in China.
To support these accreditations, in addition to annual pharmacovigilance training, all employees receive training on Good Distribution Practice, with regular training on Company procedures and policies being provided to relevant employees within the business, as needed. Those employees holding statutory roles, such as QPPV, RP, Clinicians, are expected to perform ongoing professional development as a prerequisite for holding these roles.
Our established vendor selection processes aim to ensure that all new CMOs are subject to cross-functional assessment by representatives from our Finance and Legal, Sourcing, Technical and Quality teams against a broad set of measures, to ensure compliance with Alliance’s internal policies, in addition to appropriate external quality standards, such as EU GMP, ISO 13485, ISO 22716 and GPvP, and that they have hold appropriate third party authorisations, e.g. MIA for medicines, issued by a competent authority.
Key considerations and Monitoring activities
- Supply Chain Security
- Business Ethics
- Risk-based monitoring
We recognise that, for some of our consumer products, there is a risk of counterfeit product reaching the market, which may not have been subject to the same rigorous production standards and quality testing as genuine product, rendering it potentially less effective.
In 2020, we created a new Head of Brand Protection role, to understand any potential vulnerabilities in our supply chain and address any identified counterfeiting risks.
We are also in the process of setting up a Know Your Customer (‘KYC’) programme, to bolster our customer qualification and approval processes and ensure we have full visibility over our end-to-end supply chain.
We are committed to ensuring there is transparency not only in our own business but also in our approach to tackling modern slavery throughout our supply chains, consistent with our disclosure obligations under the Modern Slavery Act 2015.
We expect the same high standards from all of our contractors, suppliers, and other business partners, and as part of our contracting processes, we include specific prohibitions against the use of forced, compulsory or trafficked labour, or anyone held in slavery or servitude, whether adults or children, and we expect that our suppliers will hold their own suppliers to the same high standards.
We carry out ongoing, risk-based monitoring of our suppliers, to ensure they remain able to supply consistent quality of materials, components, and services in compliance with regulatory requirements and to identify and mitigate any associated risks.
As part of our efforts to further improve and streamline our supplier management and associated business assurance activities, in 2020, we instigated a Know Your Supplier (‘KYS’) programme, partnering with a market-leading data aggregator / analytics provider to gain access to wide-ranging supplier data and in-depth analytics capabilities, to give us improved visibility of any potential ‘red flags’ in our supply chain. This in turn will enable us to better align existing compliance review and escalation processes, so as to ensure any identified issues are remediated on a timely basis. The initial focus has been on our direct suppliers, using a risk-based approach to selection