WHO guidelines for technology transfer in industrial pharmacy. Learn how these guidelines ensure efficient and quality-driven transfers.
What is Technolgy transfer in pharmacy?
It involves the exchange of knowledge, skills and expertise between organizations. The purpose can be developing, manufacturing or distributing pharmaceutical products. It involves sharing information, intellectual property, manufacturing processes, quality control procedures.
WHO guidelines for technology transfer
Quality Management Systems: Implementing quality management systems that encompass all stages of technology transfer, from planning to post-transfer evaluation. This includes establishing clear responsibilities, defining critical quality attributes, and conducting risk assessments.
Documentation and Knowledge Management: Comprehensive documentation including protocols, reports, and standard operating procedures. Knowledge management systems should be in place to facilitate the retention and transfer of critical information.
Training and Competence: Adequate training programs should be designed and implemented to ensure the transfer of knowledge and skills. Competence assessments should be conducted to verify the effectiveness of training efforts.
Change Control and Risk Management: A systematic approach to change control and risk management is essential to identify, evaluate, and mitigate potential risks associated with technology transfer. This includes the evaluation of potential impact on product quality, validation requirements, and regulatory compliance.
Importance of WHO Guidelines
The WHO guidelines for technology transfer in industrial pharmacy serve as a valuable resource for pharmaceutical companies, regulatory authorities and other stakeholders involved in the transfer process. These guidelines ensure technology transfers in a systematic, efficient and quality-driven manner. It focuses on maintaining product safety, efficacy, and integrity.
Conclusion
The WHO guidelines for technology transfer in industrial pharmacy provide a structured framework. It ensure the successful transfer of knowledge, skills and expertise in the pharmaceutical industry. By following these guidelines, organizations can enhance the efficiency, safety, and quality of their transfer processes, ultimately contributing to the development and availability of high-quality pharmaceutical products globally.
Also read Platform technology in Industrial pharmacy.