The regulatory environment regarding controlled temperature storage of Life Science product is changing quickly. New or revised regulations have been released in India, Europe, Canada, and the USA recently. These changes increase the breadth of the supply chain that is regulated. In short, more players need to show compliance, and they need to do a thorough job of it.
Temperature Mapping is a key strategy used in GxP environments to demonstrate the temperature uniformity necessary for safe storage of the products. With new regulations, this means that mapping studies need to be performed or reviewed by people who are new to mapping. Therefore it is of paramount importance that we can clearly and easily articulate guidelines for sensor placement.
This presentation teaches sensor placement in 5 simple rules. These rules were developed by combining years of mapping experience with recent lessons learned teaching mapping techniques to inexperienced personnel. The rules are presented in simple mathematical format that transcends language, and allowing those with limited exposure to mapping to easily and effectively determine appropriate sensor placement for a temperature mapping study. These 5 rules will also be compared to recently published guidance to demonstrate their suitability and relevance.
If you are new to performing or reviewing mapping studies, or if you must train individuals unfamiliar with mapping, knowing these rules will be an invaluable part of your training.
Paul Daniel,
Sr. Regulatory Compliance Expert
Paul Daniel is Senior Regulatory Compliance Expert at Vaisala. He has fifteen years of validation experience in the pharmaceutical and medical device industries. He has worked on a wide range of qualification projects, including process, cleaning, shipping, laboratory equipment, packaging, software, network and computer validation. He has an extensive practical grounding in applying the GMP principles found in 21 CFR Parts 11, 210, 211, and 820. His specialties include: authoring and executing validation protocols (IQ and OQ) for pharmaceutical manufacturing and software validation with a risk-based approach drawn from GAMP guidelines.
- Briefly review the global regulatory changes in GDP to appreciate the massive increase in scope.
- Review recent guidance on GDP and temperature mapping.
- Present "5 Rules" for easy and consistent sensor placement for temperature mapping.
- Regulatory Managers
- Metrology Managers
- Quality Managers
- Validation Managers
- Facility Managers
- Stability Managers
- Warehouse Managers
- Laboratory Managers
- Logistics Managers
- R & D Managers
