Pharma forum 2018

Pharma Forum 2018 11.     What do you mean by re-validation?  A repeat of the process validation to provide an assurance that changes in the  process/equipments introduced in accordance with change control procedures do not  adversely affect process characteristics & product quality.  22.     What do you mean by “worst case”?  A condition or set of conditions encompassing upper and lower processing limit and  circumstances, within standard operating procedures, which poses the greatest chance of  product or process failure when compared to ideal conditions. Such conditions do not  necessarily induce product or process failure.  33.     What do you mean by “performance qualification”?  The performance qualification documents describes the procedures for demonstrating that a  system / piece of equipment can consistently perform & meet required specifications under  routine operation and where appropriate, under worst case situations.  44.