Inspection findings – Lessons Learned from GMP/GDP Inspections

– Most common deviations in GDP/GMP

– Unexpected findings and regulatory surprises

Gain a regulatory insider’s perspective on recurring non-compliances, surprising observations, and emerging trends. Discover how to strengthen your quality systems and better prepare for future inspections—aligned with today’s regulatory expectations.

Ensuring safe returns and handling of temperature sensitive products:
Navigating Local Health Authorities and EU GDP Compliance

To accept returns of products from customers (wholesalers and pharmacies) back to saleable stock at MAH/distribution partner, EU GDP requires a certain level of controls and documentation.
This is to minimise the risk of having damaged or counterfeited products brought into the supply chain.

For temperature sensitive products, there is an additional requirement for Documented Evidence of the temperature.

– How is Documented Evidence interpreted by Local Health Authorities?

– How to navigate when MAHs are ‘asked’ by LHA to accept more returns to saleable stock due to shortage situations?

– Can we rely on the LHA control of the pharmacies in regards to handling and storing of cold-chain products? Including potential transports between pharmacy-entities?

Securing critical waste and destruction: Preventing theft, fraud, and misuse in the supply chain

To maintain the integrity and security of our operations, it is necessary that products and materials designated for destruction, referred to as “critical wastes,” are protected against theft and potential re-entry into the market for counterfeiting purposes.

We can achieve this by:
1. Mapping the Flow of Critical Waste: This process involves tracking the movement of critical waste from the point of collection to its final destruction.

2. Conducting a Risk Assessment:
This assessment will help us demonstrate that the potential risk of theft or market re-entry is minimized or significantly reduced through appropriate mitigative actions.
To break this down further:
• How is flow mapping performed?
• What factors should be considered in the risk assessment?
• What controls can be implemented to minimize the risk of theft of critical waste?

Current GMP and Regulatory updates

– GDP/GMP – most common deviations

– Deviations & findings that surprised us

Parallel importation of medicines within the EEA

Parallel importation is the practice of importing a medicinal product from another EEA country where it is already authorised, without the involvement of the original marketing authorisation holder. This is permitted under the principle of free movement of goods within the EU, but presents regulatory and operational challenges, particularly around packaging, product information, pharmacovigilance and authorization.

In this session, Guðbjörg Guttormsdóttir from the Icelandic Medicines Agency will give an overview of the regulatory framework for parallel importation, with a focus on wholesaler stock pilling, language criteria and exemptions, re-packaging operations, and common regulatory findings from inspections.