Compressed Gas Monitoring of Microbes: The Contamination Control Strategy in Pharmaceutical Manufacturing
Compressed gases, such as nitrogen, carbon dioxide, and oxygen, are used for a variety of...
Data Integrity: Understanding and Becoming Compliant with GMP and FDA Requirements
Data integrity means data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which ensures the product's quality and public safety.
In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters, but it is not a new concept.
The importance of record-keeping in drug manufacturing can be seen as far back as 1938, when the Federal Food, Drug and Cosmetic (FDC) Act required the safety of new drugs be documented before being sold to the public, with similar regulations instigated in Europe and Japan throughout the 20th century.
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Comparing Microbiological Air Monitoring Techniques for Critical Environments
This whitepaper explores the use of active air and passive air settle plate monitoring for...
The IsoAir® Pro-E, a Next Generation Remote Particle Counter
Particle Measuring Systems (PMS) is pleased to announce the release of its new IsoAir® Pro-E...
Test Apparatus For Parental Drugs for Injection
For preciseness, accuracy, and internal regulation compliancy, parental drugs for injection require test apparatus for...