Cleaning Validation

Technical
The process life-cycle model, as discussed in the US FDA guidance on process validation, is a significant change in how we view validation.US Food and Drug Administration. “Guidance for Industry. Process Validation: General Principles and Practices.” January 2011....
Video
Learning Level: Basic/Intermediate/Advanced - This Webinar summarizes the recently published ISPE Guide on Cleaning Validation. It will present the guide topics, key principles and current approaches for the...
Guidance Docs
Thisguide provides a hands-on approach to support the life science industry in the development and establishment of compliant cleaning programs that meet or exceed regulatory expectations.
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17 September 2020
News & Press Releases
ISPE announced the release of its latest Guide, ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, and Controls. The Guide was written by a group of experts and reviewed by regulators and practitioners in the field, delivering a...
Technical
It is a common practice in the pharmaceutical and biopharmaceutical industries to execute a factory acceptance test (FAT) for equipment involved with various drug manufacturing processes. The FAT is a project milestone in purchasing good manufacturing practice–compliant equipment.
Special Reports
In recent years we have observed misunderstanding and confusion over correlation between the 2004 US Food and Drug Administration (FDA) environmental cleanliness requirements for sterile product manufacture 1 and those of the European Medicines Agency...
Training
Clean-in-place design integration and cleaning chemical selection are vital components of every pharmaceutical manufacturing process; indeed, all pharmaceutical companies employ some type of cleaning application every...
Training
This course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA /....