GDP Insights for Compliance and Business Continuity

Blockchain & Security Features

Medicine traceability, oversight and security features is the first goal in the 3-year work plan for the EMA Inspectors Working Group [1]. Improvements are planned for both the EudraGMDP database and to improve expertise in safety features. The inspectors will liaise with the expert group on the delegated act on safety features for medicinal products for human use for the inspection of the repositories systems. Is your operation of serialisation activities and responsibilities inspection ready? MIAS Pharma can guide you through inspection readiness, perform mock audits and help you implement, review, or optimise your serialisation processes and procedures.

In line with this the industry is innovating with blockchain as an end-to-end traceability solution for high-value or temperature-sensitive products. Blockchain provides location-based tracking for transparency and security.  Are your controls and quality agreements GDP-ready for this new era of supply chain security?

Geo-Political Risks

Medicine supply chains now involve global distribution challenges including customs, tariffs, quality oversight of third-party logistics providers (3PLs), and storage facilities.  Outsourcing to multiple partners requires diligent contract management and GDP compliance auditing.

GDP Non-Compliance Reports published on EUDRA GMDP from the past year show no less than 9 organisations distributed throughout Europe where WDAs were withdrawn due to non-compliance with GDP.

Compliance Risks – a taster

• Unqualified Suppliers or Customers:  Are your supplier/customer qualification files verified annually? This is a common health authority observation, cited as “inadequate qualification and periodic verification of customers and suppliers”. It is critical to ensure that your audit program aligns with the scope of the services outsourced and that this is supplemented with robust quality oversight.
• Control of Supply Chain: Mapping, qualification & assurance of transportation routes in routine operations – is your system controlled through change management?
• Training Gaps:  Annual GDP training should be provided to all staff, with documented proof. Additionally, personnel need to understand GDP principles and demonstrate how to apply GDP practically. This requirement is often interpreted as the annual refresher GDP training. However, citations have been issued for lack of staff training on falsified medicine risks. Are you well placed to demonstrate the effectiveness of the training delivered to your personnel?
• Inadequate Quality Management System: Common deficiencies include lack of documented procedures, poor change control and risk management practices and failure to regularly review and update the Quality System.
• Responsible Person handling of Returns and Recalls: You must demonstrate your RP is continuously contactable and has the appropriate authority.   They are responsible to actively overseeing recalls, complaints, or supplier/customer approvals.
• Inadequate Contracts: Another common citation is that contracts lack clear roles and responsibilities.

MIAS Pharma offers end-to-end support for WDA holders, helping you maintain a robust Quality Management System, prepare for inspections, and support your evaluation of supply chain security.

MIAS Pharma is your trusted partner for ongoing compliance and operational excellence. Our team of experienced Responsible Persons (RPs) and regulatory experts provide tailored support to help you maintain, optimise, and future-proof your GDP-compliant Quality Management System. Whether you need gap analysis, supply chain qualification, RP services, or GDP training and audits, we ensure you stay ahead of evolving requirements – so you can focus on your business with confidence.