Cleaning Validation

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 /....
iSpeak Blog
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...
Technical
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.