Cleaning Validation

GXP
This paper considers some of the potential causes for wet loads and addresses some of the measures that can be taken to address occurrences.

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Video
“Know and understand the cleaning processes you must validate” Dawn Tavalsky orated in the finale of her workshop at 17th...
Article
The following proposed standard is intended to reflect desirable contemporary practices, is not binding in any way, and can be...Download
JVT
For multi-product biopharmaceutical facilities, setting the acceptable level of process residues following equipment cleaning...Download
JVT
While considerable attention has been given to the development of visual residue limits (VRLs) in a laboratory setting,...Download
The staff of IVT were onsite at the 2015 EU Validation Week held in the center city of Amsterdam's Crowne Plaza Hotel. Check out some photos from the conference's opening speeches.
At IVT's 17th Annual Validation Week, Dawn Tavalsky gives a must-see presentation for any organization looking to implement or reimplement a cleaning validation program from scratch. At the beginning of the presentation, Tavalsky discusses the definition of cleaning validation; the FDA, Health Canada, and European regulatory expectation for cleaning validation; and the realistic scope of a...
GXP
This paper has discusses the implications of the process hold times on microbial growth during pharmaceutical manufacturing. Microbiological risk exists -- especially with biological products. If microbial contamination occurs where microorganisms enter a product in sufficient numbers and if the process hold time is long enough, the process hold time may be problematic.
Special Edition
A scientific approach to cleaning validation is robustly explained in this special edition. Cleaning validation as it applies to all aspects of the product lifecycle are discussed, including topics on: Equipment cleaning validation, Cleaning validation documentation, Total organic carbon analysis, and Detergent selection.
GXP
Certain pharmaceutical products must be sterile, including injections, ophthalmic preparations, irrigations solutions, and hemodialysis solutions. This is due to the route of administration and in relation to the intended patient population. The first paper looked at designing media fills for multiple product lines, by using a matrix; the second considered how interventions can be risk assessed.

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