Step-by-Step Process for Successful Sterility Failure Investigations
Автор: Camel camouflage
Загружено: 2021-04-01
Просмотров: 366
Описание:
There are many different types of microbial contamination that can occur in pharmaceutical manufacturing. Some of the sources include: water, raw materials, excipients, in-process materials and samples, the manufacturing process, the product itself, and the general manufacturing environment. As such, there is no one size fits all investigation.
Microbiological testing covers a wide range of products, processes and environments, therefore representative samples from each of these categories forms the basis of what gets investigated. The role of QC Microbiology in the identification and investigation of various results from manufacturing areas and finished product testing is extremely important.
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