It is crucial that pharmaceutical products adhere not only to high-quality standards as per Good Manufacturing Practice but also maintain their quality and integrity throughout the entire supply chain, up to the patient.
In today's pharmaceutical landscape, ensuring the safe and reliable distribution of medicinal products is more critical than ever. The complexities of the pharmaceutical supply chain, coupled with the rising threat of counterfeit drugs infiltrating legitimate channels, underscore the necessity for robust Good Distribution Practice (GDP) standards. Good Storage and Distribution Practices (GSP, GDP) are paramount throughout the life cycle of pharmaceutical products and Active Pharmaceutical Ingredients (APIs).
European regulations state the importance of implementing quality systems, risk management principles, and clearly defined processes to safeguard pharmaceutical integrity. Pharmaceutical distributors must establish comprehensive quality systems that define roles, processes, and risk management strategies to mitigate these challenges effectively.
This training course addresses the imperative for pharmaceutical distributors to adhere to GDP guidelines meticulously. Participants will gain thorough understanding of the roles responsible for implementing these practices and the critical junctures within the supply chain where they are most crucial. Discussions will focus on practical strategies for maintaining the quality, potency, integrity, and identity of pharmaceutical products from raw materials through to final distribution, ensuring compliance and safeguarding patient safety.
Benefits of attending
- Gain a comprehensive understanding of international GDP guidelines and regulations
- Explore supply chain risks and effective mitigation strategies
- Identify causes and explore solutions for drug shortages
- Acquire knowledge on cargo security protocols
- Receive expert guidance on detecting and preventing counterfeit drugs in the supply chain
- Learn storage and transportation requirements for pharmaceutical products in alignment with current pharmacopoeias
- Understand risks associated with transporting temperature-sensitive pharmaceuticals
- Obtain detailed insights into equipment qualification for storage, transport, and distribution
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Course Content
Day 1