The Responsible Person (RP) and Their Responsibilities for Good Distribution Practice

Know Your Medicines Supply Chain

When wholesaling in medicines, it is required to purchase, store and distribute medicinal products in such a manner that the quality, safety, identity, purity and efficacy of the pharmaceuticals is not compromised.

The primary concern of the RP is patient safety. This is assured by maintaining product quality. To achieve the quality objective reliably, there must be a comprehensively designed Quality Management System (QMS). Quality management is achieved through:

  • 1) The RP – A program for the systematic monitoring and evaluation of the various aspects of our service to ensure quality standards are met as per the brainstorm diagram;
  • 2) Standardisation of processes and procedures;
  • 3) Continuous quality improvement;
  • 4) Regulatory compliance with the principles of Good Distribution Practice and Quality Risk Management.

All departments which physically handle the product or product information, shall be adequately resourced with appropriately qualified, experienced and competent personnel. The QMS shall consist of formalised processes and procedures, and supported by sufficient premises, equipment, services and utilities.

The attainment of the quality objective is the responsibility of senior management and requires the participation and commitment by staff at all levels within the company as well as the suppliers and vendors utilised in your supply chain.

Inglasia Pharma Solutions