Our Commitment
to Medicine Quality.

01Purpose

This policy communicates the standards Euro Biom applies to the wholesale and export of medicinal products under our MHRA Wholesale Dealer Authorisation. It is designed to be read by our staff, our customers, our suppliers and by regulatory authorities, and is maintained as part of our Quality Management System.

02Scope

This policy applies to all activities carried out under WDA(H) 59239, including:

• Procurement of UK-licensed finished medicinal products from MHRA-licensed manufacturers and approved wholesalers
• Receipt, quarantine, storage, picking, packing and dispatch at the contract storage site
• Supply to UK hospitals, clinics, licensed pharmacies, wholesalers and institutional buyers
• Export to overseas hospital groups, ministries of health, NGOs and registered distributors across the GCC, Africa, Europe, CIS and Southeast Asia
• 2-8°C cold chain supply of UK-licensed medicines, arranged through the contract storage site and carriers
• Supply of UK-licensed medicines to buyers using a destination country's named-patient import route

03Regulatory Framework

Euro Biom operates in line with:

• The UK Human Medicines Regulations 2012 (as amended)
• UK Good Distribution Practice (GDP) for Medicinal Products for Human Use
• MHRA guidance for wholesale dealers
• The falsified medicines provisions of the Human Medicines Regulations 2012
• UK export controls, sanctions regulations and HMRC customs requirements
• Applicable destination-country pharmaceutical regulations (SFDA, NAFDAC, DHA, EDE, PPB, FDA Ghana and equivalents)

04Leadership and Responsibilities

Overall responsibility for the quality of Euro Biom's operations rests with the company's Directors. Operational responsibility for GDP and quality decisions sits with the Responsible Person (RP) named on our WDA.

• Responsible Person: Mr Brian Lindsay, accountable under the Human Medicines Regulations 2012 for ensuring WDA compliance, including staff training and the escalation of quality concerns.
• Directors and Senior Management: Accountable for providing the resources, staffing, premises, systems and budget required for quality to be achieved and maintained.
• All staff: Responsible for following documented procedures, raising any observed deviation, and cooperating with audits, inspections and recall procedures.

05Our Quality Commitments

In each customer relationship, Euro Biom commits to:

• Source only through the UK licensed supply chain: MHRA-licensed holders and licensed UK wholesalers
• Maintain a documented, risk-based Quality Management System covering procurement, storage, distribution, recall, complaint, deviation, change control and self-inspection
• Require that all medicines are stored and handled at the contract storage site within the manufacturer's specified temperature range, with calibrated monitoring and qualified personnel
• Qualify and periodically re-qualify every supplier and every customer, maintaining current evidence of licensure on file
• Maintain batch-level traceability from incoming receipt to final consignee, enabling rapid product recall if required
• Operate every supply under the oversight of the Responsible Person named on our licence
• Investigate, document and, where necessary, escalate every deviation, temperature excursion, complaint and returned product
• Support the MHRA, destination-country regulators and our customers with prompt, accurate and transparent documentation on request
• Continuously improve our quality performance through management review, staff training, self-inspection and customer feedback

06Supplier and Customer Qualification

We do business only with counterparties whose regulatory status we have verified. Before first order, and at regular intervals thereafter, we confirm:

• Valid, current manufacturing or wholesale authorisation as applicable
• Authorisation to handle the product class required (POM or GSL as applicable)
• Where the counterparty is an overseas customer, their equivalent national authorisation
• Absence from applicable sanctions or restricted entity lists

07Cold Chain Handling

Temperature-sensitive medicines are shipped from the contract storage site as follows:

• 2-8°C shipments are packed by the contract storage site in temperature-controlled packaging
• Cold chain consignments are shipped with a data logger, arranged with specialist carriers
• Any excursion is investigated, documented and reviewed against manufacturer stability data before product release or rejection
• Detail on how 2-8°C shipments are handled through our contract storage site is published at cold chain pharmaceutical supply

08Product Recall and Pharmacovigilance

We maintain a documented recall procedure designed to contact affected customers promptly on receipt of an MHRA alert. Affected stock is uplifted, destroyed or returned in accordance with the alert. We cooperate with the MHRA's pharmacovigilance systems and forward relevant safety information received from suppliers or customers to the appropriate authority.

09Audit, Inspection and Review

Euro Biom's quality system is subject to:

• MHRA inspection against UK GDP standards
• Internal self-inspection against a documented audit programme
• Management review at least annually against key quality performance indicators
• Customer audits considered on request, under mutual confidentiality terms

The outputs of each review feed directly into continuous improvement actions tracked through our change control procedure.

10Contact and Feedback

Quality concerns, complaints, and feedback on any aspect of our service should be addressed to the Responsible Person or to the operational team at work@eurobiom.co.uk. We welcome scrutiny, we respond to every quality query, and we treat every complaint as an opportunity to improve.