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 /....
1. Why is cleaning and cleaning validation so crucial to the pharmaceutical industry?
Cleaning and cleaning validation are of crucial importance to patient safety. Only by ensuring that our process equipment is clean through a reproducible process can...
This article presents the standards and guidelines typically used by manufacturers to design and build GMP washers and sterilizers. It describes the characteristics that differentiate GMP from regular laboratory equipment.
