Apr 25, 2013
By:
Vaisala
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.
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Mar 28, 2013
By:
Vaisala
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.
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Jan 30, 2013
By:
Vaisala
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.
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Dec 18, 2012
By:
Vaisala
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.
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Nov 1, 2012
By:
Vaisala
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.
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Sep 25, 2012
By:
Vaisala
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.
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Aug 28, 2012
By:
Vaisala
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.
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Jul 31, 2012
By:
Vaisala
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.
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Jun 26, 2012
By:
Vaisala
In this collection four experts discuss several ways to reduce the risks of failed inspections, bad measurement practices, and poor product quality in controlled environments. Topics span from measurement accuracy, uncertainty, stability, and traceability, to a discussion of wired v. wireless connectivity for sensing instruments, to FDA inspection preparation and 483 responses. These articles offer a surfeit of tweaks, tips, and tricks for developing better quality management systems for GxP-compliant environmental monitoring applications.
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