Chapter 2 (Personnel) of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01) defines the qualification requirements, tasks and responsibilities of all staff and the Responsible Person (RP). "There must be sufficient competent personnel to carry out all the tasks for which the wholesale distributor is responsible."
Training requirements for all staff including the RP are defined, there is a need for up to date training records, staff should receive training on tasks they perform, products they handle and the GDP guidelines. The practical effectiveness of training should then be periodically assessed and documented for all staff.
Checklist: Implementation of GDP Principles at Wholesale Distributors
The following checklist provides a generic overview and could be used as a minimum requirement related to Chapter 2 of the 2013 guidelines:
A Responsible Person is appointed
The RP meets the requirements of national legislation
The RP has the appropriate competence and experience required to perform their role for the size of the organisation
The RP has knowledge of GDP
The RP has received and is receiving ongoing GDP training
The RP has a clear written job description defining their authority to take decisions with regard to their responsibilities
The RP has sufficient authority, resources and responsibility to fulfill their duties
The RP can demonstrate their compliance to GDP as a minimum for - The Quality Management System - Authorised activities - Accuracy and quality of records (documentation) - The training programme - Recall operations - Customer complaints - Supplier qualification - Customer qualification - Approval of sub-contracted/outsourced activities impacting GDP - Selfinspection - The record of delegated duties - The final disposition of returned, rejected, recalled, falsified products - Approval of returns to saleable stock
Sufficient personnel are employed for the size and type of business
Responsibilities and roles of employees working in key positions is defined in written job descriptions, including arrangements for deputy duties
All personnel involved in wholesale distribution activities are trained in GDP requirements
Training includes aspects of product identification and avoidance of falsified medicines entering the supply chain, as well as checking documents for accuracy and potential falsification
Specific training is provided where indicated and for specific duties e.g. - Handling of hazardous products, radioactive materials as well as products presenting special risks of abuse, narcotics or psychotropic substances, or temperature sensitive products - Processing purchase orders for narcotics and psychotropics and applying controlled drugs/narcotics permits from local authorities - Storage of products procured from / to third countries
Personnel receive initial and continuing training relevant to their tasks, based on written standard operating procedures (SOPs) according to a written training programme
The practical effectiveness of training is periodically assessed and documented
Appropriate procedures relating to personal hygiene are established
The points listed above are an excerpt from the "ECA Roadmap to Good Distribution Practice (GDP)", which includes checklists to verify the minimum implementation of GDP, based on the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01). The European GDP Association (GDPA) has compiled this document to support pharmaceutical and wholesaler businesses in implementing regulatory requirements and expectations in their quality systems. The PDF is available for download free of charge in the GDPA members' area.