Good Distribution Practice (GDP) – Frequently Asked Questions

placeholder

Good Distribution Practice (GDP) – Frequently Asked Questions

Good Distribution Practice (GDP)

Good Distribution Practice (GDP) are the EU guidelines that describe the minimum standards that a distributor must meet to ensure that the quality and integrity of medicines and other healthcare products is maintained throughout the supply chain.

GDP Guidelines apply to pharmaceutical products, active pharmaceutical ingredients and medical devices.

Being GDP compliant ensures that:

·       the product is authorised by EU legislation

·       medicines are always stored in the right conditions

·       contamination is avoided

·       adequate supply is maintained

·       products are delivered within acceptable time frames

As GDP governs the safety of healthcare products throughout the supply chain, all companies involved in the manufacture, handling and delivery of pharmaceutics and medical devices should be GDP compliant. This includes pharma and med tech companies, but also companies responsible for logistics and transportation

Developed by the Irish Exporters Association (IEA) in consultation with the Health Products Regulatory Authority (HPRA), the GDP Passport programme is the industry standard qualification for GDP compliance. The programme consists of a full suite of certified trainings for all relevant staff including quality managers, operations staff and drivers

The four certified stages are:

·       GDP Champion

·       GDP Operations

·       GDP Drivers

·       GDP Audit

The GDP Champion is for the staff member with overall responsibility for GDP compliance in the organisation. GDP Operations trains the relevant site, office or warehouse staff in their responsibilities and GDP Drivers provides certification and an ID card to drivers responsible for the safe handling and delivery of the product. Finally, an audit is conducted to ensure the organisation is fully GDP compliant throughout its operations and supply chain.

Companies should begin by training a GDP Champion as this is the person who will have overall management for GDP at the organisation and will be the key point of contact for GDP audits.

For further advice on the process, please contact the IEA training team on +353 (0)1 661 2182 / training@irishexporters.ie.

The time needed to prepare for a GDP audit will depend on what GDP-related activities your organisation is engaged with, for example just point-to-point deliveries or deliveries that involve cross docking, and on what activities are outsourced. It may also depend on whether your organisation has been through the auditing process before and if all appropriate Standard Operating Procedures (SOPs) and staff training are in place.

Remember that GDP Passports expire after two years so, for recertifying companies, beginning your audit planning well in advance is essential.

If you would like advice on when to book an audit, please contact the IEA training team on +353 (0)1 661 2182 / training@irishexporters.ie. 

All staff involved in the management, administration and transportation of healthcare products should take the relevant training. This does not mean that all staff in an organisation need to be trained. However, all staff whose duties could impact the safety and quality at any point of the supply chain will need to undergo certified training.

The GDP Champion has overall responsibility for GDP compliance, so this person is likely to be a safety and quality manager, supply chain manager, site manager or similar.

GDP Audits are comprehensive and cover a broad range of safety and quality areas including Standard Operating Procedures (SOPs), your quality manual, staff training, outsourcing contracts, goods return processes and other relevant areas. A copy of the Code of Practice (COP) and auditing checklist will be provided on engagement with the programme. After an audit, the GDP auditor will draft a report within two weeks. The Life Sciences Ireland (LSI) Steering Committee will then have one week to review the audit report. The Passport will then be issued to the company provided no further follow-up actions are requested by the auditor or LSI Committee.

If a company cannot provide all requested documentation on the day of an audit, they will be required to send the documentation to the IEA within two weeks of the audit day. In special circumstances such as key personnel being on leave, additional time may be granted on a case-by-case basis.

Where a facility such as a warehouse has been approved by the HPRA for wholesale distribution authorisation (WDA) status, this specific facility will be recognised as having high GDP standards already in place. The organisation can undergo a regulator-authorised facility audit in place of a full audit. Similarly transport only audits for operators without warehousing will not require a full GDP Passport audit. 

The GDP Passport and all GDP training certificates are valid for a period of 2 years. GDP Champions can attend a one-day Refresher training. Drivers and Operations staff will need to complete online training again after two years.

The Life Sciences Ireland (LSI) Steering Committee oversees the quality of GDP training and has final sign off on audit reports. The LSI Steering Committee comprises of industry representatives, GDP auditors and IEA staff and meets once per quarter.

The IEA GDP Code of Practice (COP) aligns with the EU GDP guidelines and provides comprehensive detail on the scope and responsibilities of GDP for organisations engaging with the GDP Passport programme. Organisations should use the COP as a framework for the development of their procedures and best safety practice.

The COP is revised annually, and updated versions are sent to GDP Passport holders.

Subsidised rates for GDP training are available from CILT Skillnet to qualifying companies based in the Republic of Ireland.