As long as the process operates in a state of GMP control and no changes have been made to the process or output product, the process does not have to be revalidated. Whether the process is operating in a state of control is determined by analyzing day-to-dayprocess control data and any finished device testing data for conformance with specifications and for variability.


When equipment is moved to a new location, installation and operation should be requalified. By comparing data from the original installation and operation qualification (IQ and OQ) and the requalification, the manufacturer can determine whether there have been any changes in equipment performance as a result of the move. Changes in equipment performance should be evaluated to determine whether it is necessary to revalidate the process.


Part 820.75 of the QS regulation requires that validated processes be monitored and controlled so that when changes or process deviations occur, a manufacturer will know to review and evaluate the process and perform revalidation when appropriate. 21 CFR 820.75(c ) requires you to have documented procedures in place for evaluating; when revalidation is required.


Recent research has highlighted that in the pharmaceutical and bio-medical industry, thirty two percent of all equipment procurements are unsatisfactory. The major problem has been identified as companies not specifying in sufficient detail and or accuracy, what their actual needs are. The lack of a quality company approved UserRequirements Specification (URS), leads to many companies having to resort to otherwise un-necessary and costly retrospective actions in modifying the equipment or producing unspecifieddocumentation or engineering drawings, post procurement. These extraneous GMP requirements often cost more than the equipment.

No comments: