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....
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...
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.
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...
BACKGROUND
Since the initial discussions on Cleaning Validation in the early 1990’s and even after the FDA Guidance was published in 1993, there has been a lot of confusion related to the application of the Cleaning Validation (CV) requirements in our...
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.
What is cleaning validation and where does it fall in the life cycle validation scheme? How can an automated washing system be validated? This article provides insights that may help answer these questions.
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...
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...
This course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA /....
