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Roles and Responsibilities of Responsible Person for GDP - Quality System - Authorized Activities – Training

Roles and Responsibilities of Responsible Person for GDP – Quality System – Authorized Activities – Training

In my next series of blogs, I will discuss more in details the Role and Responsibilities of the Responsible Person for Good Distribution Practice (GDP).

When a Responsible Person for a company is appointed, it is important to understand what Roles and Responsibilities this person carries for this organization.

In this article the first 3 points are discussed:

  • ensuring that a quality management system is implemented and maintained
  • focusing on the management of authorised activities and the accuracy and quality of records
  • ensuring that initial and continuous training programmes are implemented and maintained;

Ensuring that a quality management system is implemented and maintained

The best way to proceed is to have a direct involvement and contribution of the Responsible Person GDP in the set-up of quality system, writing/reviewing of procedures, implementation and regular maintenance of the quality system. In doing so, the organization can ensure that Responsible Person GDP fulfills this requirement and compliance with GDP is assured. The Responsible Person GDP must be kept in the loop of any proposed changes that may have an impact on the quality system and/or regulatory compliance. The Responsible Person for GDP can advise the organization on improvements and ensure best industry practices are embedded in the quality system. The Responsible Person GDP should actively contribute to and participant management review meetings where quality metrics are discussed, concerns regarding any negative trends highlighted and corrective actions agreed and monitored.

Focusing on the management of authorised activities and the accuracy and quality of records

The Responsible Person GDP must be actively involved in application for a new or revision of existing Wholesaler Distribution Authorization (WDA). This will allow the Responsible Person GDP to ensure he/she is aware of the details of the WDA. In doing so, the Responsible Person GDP can adapt the quality system and documentation to the actual GDP-situation. The Responsible Person GDP should develop a procedure to define the GDP relevant records and how they should be checked for accuracy and quality. Some authorities may permit some of these checks to be delegated to appropriately trained personnel. However, overall accountability for accuracy of the records will remain with the Responsible Person GDP. The Responsible Person GDP must ensure he/she is fully aware of Data Integrity requirements and the Good Documentation Practice principles are applied.

Ensuring that initial and continuous training programmes are implemented and maintained;

The Responsible Person GDP is in the most of companies closely involved in establishing and approving the training programme for the entire organization. When the Responsible Person GDP is the owner or author of a procedure, it is also advisable that the Responsible Person GDP conducts the training for these processes itself. This approach enables the Responsible Person GDP to explain and inspire the organization at all levels about the need and importance of GDP and processes. It gives the Responsible Person GDP also an opportunity to understand how various aspects of the quality system affects people in their job. Training records should be reviewed by the Responsible Person GDP during the self-inspections. The Responsible Person GDP should review completion status of the training plan and work on any gaps/delays to training plans with relevant functions within the organization.

The Responsible Person GDP must also attend appropriate training courses to ensure continued current knowledge of GDP requirements and regulatory authority expectations.

In my next blog I will discuss the next point ‘Coordinating and promptly performing any recall operations for medicinal products’.

Kristina Bindus

• Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality & Regulatory Affairs.
• Co-founder of Webcaststudio.be and Belgian internet radio Singjaal.
• Strategic Advisor & Trainer specialized on interpretation & implementation of EU pharmaceutical law who cares about Quality, Safety and Efficacy of Medicines.
• Kristina is specialized in online medical communication: webcast, webinar and e-learning.
• She has developed universal auditing techniques and coaches auditors to use auditing methodology for an effective assessment result.
• Kristina has an extensive experience in Quality & Pharmacovigilance.

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