Vaisala

Download the new Application Note ?Better Stability Studies: Match Your Environmental Monitoring & Mapping to FDA/ICH Guidance.? Learn how to minimize the risk of incomplete data from power or network failures during environmental mapping/monitoring applications and ensure stability study data complies with FDA/ICH guidance.

Vaisala makes the world's finest humidity sensors and in this article, we describe several observations on humidity measurement in controlled environments. We hope this information will help you clarify your approach to controlling and monitoring this hard-to-measure parameter.

This peer-reviewed paper (published in the Journal of Validation Technology) focuses on two sensors used in thermal mapping: thermocouples and thermistors, and describes advantages and disadvantages of both, describing why thermistor-equipped data loggers can be used to perform mapping studies in GxP-compliant environments.

The FDA mandates validation of incubators, refrigerators, freezers, stability chambers, warehouses, and other controlled environments. Download this NEW application note, which covers five key questions you need to have answered in planning a compliant temperature and humidity mapping study.

This paper looks at the five general chapters of the updated and revised United States Pharmacopeia and The National Formulary (USP 33?NF 28) that touch upon the temperature-sensitive supply chain.

This paper provides an overview of the Parenteral Drug Association’s technical report 39, best practices for writing a performance qualification protocol, and principles to help qualify multiple points in a temperature-controlled supply chain.

This article shows excerpts from recent 483s issued for deviations in tracking and recording environmental parameters in various applications. The article outlines ten best practices of a 483 response, providing a checklist to make the 15-day response time limit more manageable. Included are multiple links to further reading, agency guidelines, and disputation information.

This paper discusses a scientific approach to cold chain management, overview of ICH guidance, three key FDA regulations, and examples of cold chain 483 observations.

This step-by-step guide describes how to map a warehouse to comply with internationally recognized GMPs—including many that have been published or revised recently. It draws on Vaisala’s extensive experience in environmental and industrial measurement and monitoring throughout over 140 countries.