Business Imperatives

  • A leading transportation and logistics company in the United States required assistance in establishing a single Quality Management System (QMS) for Good Distribution Practices (GDP), implementing this system across their global sites, and obtaining GDP certification from the US Regulatory authority.

Objectives

Assist an American transportation and logistics company with expertise in handling pharmaceutical products globally in obtaining a GDP certificate and helping them understand the relevance of GDP to their business.

Problem Statement

  • The client was at risk of losing out of business to their potential customers due to GDP non-compliance. 
  • The client did not have an established / in-use quality management system in place to govern the current system and services. 
  • Lack of understanding of GDP relevance to their business  
  • Lack of GDP compliance requirements expertise 

Freyr Solutions and Services

Freyr Solutions and Services
  • Freyr proposed a BOT (Build, Operate, Transfer) solution program, featuring dedicated expert support, aimed at establishing QMS (Quality Management System). 
  • Ensured that the client comprehends and adjusts to global Regulatory compliance and quality standards for distribution.  
  • Practiced (GDPs), safeguarding the safety and quality of medicines during delivery. 
  • Supported the implementation of established processes and provided training to pertinent stakeholders. 
  • Focused on Regulatory Requirements for GDP certification. 
  • Developed comprehensive policies and procedures that outline GDP requirements. 
  • Established a robust documentation system to record all activities. 
  • Regular internal audits were conducted to assess the effectiveness of their QMS and identify areas for improvement. 
  • Once the QMS met the requirements of GDP certification, audits were conducted. If the audit was successful, GDP certification was received. 
  • Streamlined 60+ SOPs and regulations guiding and ensuring good distribution practices (GDPs) to preserve medicine safety & quality during delivery. 
  • Access to a wider pool of potential customers was gained due to full compliance. 
  • 100% GDP compliance was achieved, adhering strictly to all the guidelines. 
  • Successfully established one QMS for GDP (Good Distribution Practices) through the 'BOT- Build, Operate, Transfer' model of the solution program. 
  • Implemented the QMS across global sites with expert and dedicated support. 
  • Facilitated GDP certification by the respective Regulatory body. 
  • Obtained GDP certificate by maintaining quality management systems that demonstrated quality and integrity.