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Temperature control is critical to maintaining the quality, safety, and integrity of pharmaceutical products. Health Canada’s Guide 0069, Temperature Control of Drug Products during Storage and Transportation, requires that drug products be handled, stored, and transported within their labeled temperature conditions to prevent excursions that may compromise product quality. Effective temperature management across ambient, refrigerated, frozen, dry ice, and liquid nitrogen conditions is essential throughout the product lifecycle.
This workshop provides a practical overview of GMP Temperature Mapping and its role in supporting regulatory compliance and operational control. Participants will explore best practices for managing temperature across a wide range of storage and transportation environments, including rooms, warehouses, freezers, fridges, incubators, trailers, tanks, and shipping containers. The session also covers when temperature mapping should be conducted, including routine assessments, following equipment or process changes, and when unexplained temperature variability is observed.
Beyond compliance, temperature mapping generates valuable data that supports real-time monitoring and informed decision-making. Through this workshop, participants will gain an understanding of how to design and execute temperature mapping studies, analyze data, prepare clear summary reports, and interpret findings to maintain consistent product conditions and support continuous improvement. The session is suitable for professionals involved in quality assurance, logistics, and regulatory compliance, as well as those seeking to strengthen their understanding of temperature control within pharmaceutical, biotechnology, and medical device environments. |
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