Our advanced Good Distribution Practice (GDP) training covers crucial aspects of wholesale distribution, ensuring compliance with rigorous standards.
Firstly, we delve into the guidelines that define the standards a distributor must meet, providing a comprehensive overview of these requirements.
Next, we focus on preventing the infiltration of falsified medicines into the distribution chain. Key topics such as transport and incoterms are discussed in detail. Ensuring goods remain undamaged during transport is paramount, particularly for temperature-sensitive drugs, where proper storage is essential for efficacy and safety. Incoterms clarify the responsibilities of parties involved in transportation.
The Change Control chapter outlines how organizations should handle significant changes, encompassing all areas of the quality control system. An effective Change Control system supports systematic, documented approaches and incorporates quality risk management principles. Third-party suppliers must meet quality requirements to maintain compliance.
Quality contractual agreements facilitate clear communication between parties, defining tasks and responsibilities to prevent misunderstandings affecting compliance.
The next chapter focuses on audits, self-inspections, and Corrective And Preventive Actions (CAPA). Self-inspections verify compliance with quality systems and GDP guidelines, identifying areas for improvement. Auditors conduct objective assessments, communicating results and investigating non-conformities. CAPA actions are proportionate and aimed at continuous improvement.
Pharmaceutical wholesalers must establish a robust quality system, outlining responsibilities, processes, and risk management principles. This system ensures product quality and integrity throughout storage and transportation within the legal supply chain. Documentation and monitoring ensure the system's effectiveness, with all quality-related activities clearly defined and documented.
Firstly, we delve into the guidelines that define the standards a distributor must meet, providing a comprehensive overview of these requirements.
Next, we focus on preventing the infiltration of falsified medicines into the distribution chain. Key topics such as transport and incoterms are discussed in detail. Ensuring goods remain undamaged during transport is paramount, particularly for temperature-sensitive drugs, where proper storage is essential for efficacy and safety. Incoterms clarify the responsibilities of parties involved in transportation.
The Change Control chapter outlines how organizations should handle significant changes, encompassing all areas of the quality control system. An effective Change Control system supports systematic, documented approaches and incorporates quality risk management principles. Third-party suppliers must meet quality requirements to maintain compliance.
Quality contractual agreements facilitate clear communication between parties, defining tasks and responsibilities to prevent misunderstandings affecting compliance.
The next chapter focuses on audits, self-inspections, and Corrective And Preventive Actions (CAPA). Self-inspections verify compliance with quality systems and GDP guidelines, identifying areas for improvement. Auditors conduct objective assessments, communicating results and investigating non-conformities. CAPA actions are proportionate and aimed at continuous improvement.
Pharmaceutical wholesalers must establish a robust quality system, outlining responsibilities, processes, and risk management principles. This system ensures product quality and integrity throughout storage and transportation within the legal supply chain. Documentation and monitoring ensure the system's effectiveness, with all quality-related activities clearly defined and documented.
For whom
This self-study program is designed for:
- Experienced Responsible Persons in Good Distribution Practice
- Responsible Persons seeking to enhance and refresh their understanding of Good Distribution Practice
- Managers within pharmaceutical wholesale companies, including those pursuing a European pharmaceutical wholesale license
- Quality Assurance managers
A solid understanding of GDP fundamentals is strongly advised.
Practical arrangements
- This is a self-study program
- Note pages are available in pdf format
- Participants who require a training certificate can take a multiple choice quiz (50 items, at least 45 correct answers are required to qualify)
Course details