This Web Seminar will present a comprehensive overview of the life-cycle approach to cleaning for product contact surfaces of equipment in the pharmaceutical industry. The four phases of cleaning : cleaning assessment, cleaning development, cleaning validation and cleaning monitoring will be discussed including how they contribute to a compliant, evolving cleaning program.
The cleaning assessment phase evaluates either the current cleaning procedure or a proposed change to the current cleaning procedure against the current regulatory cleaning validation expectations. Any necessary remediation strategy for the assessment is determined in order to define an efficient cleaning development study.
The cleaning development phase takes the cleaning assessment and develops a protocol describing any needed cleaning development activities including critical quality attributes (CQA) and critical process parameters (CPP) for the proposed cleaning procedure. If cleaning development is not deemed necessary, a single confirmation run for the proposed change is required prior to validation.
The cleaning validation phase will provide documented evidence through an executed protocol which provides a high degree of assurance that a cleaning procedure consistently removes residues to pre-determined acceptable levels and the cleaning procedure process capability parameters can be established to provide ongoing assurance that the cleaning procedure remains in a state of control.
The cleaning monitoring phase will provide documented evidence through an SOP or executed protocol that the validated cleaning program remains in a state of control. Annual document review including non-conformances, and change control evaluate whether the cleaning procedure under review continues to be effective and has not undergone changes that might impact the validated state of the procedure. Periodic testing, as described in an annual schedule, will demonstrate continued control of the cleaning procedures.
Change controls affecting the validated cleaning procedure will trigger the need for a cleaning assessment and restart the cycle. Change control can be the result of additions of products or equipment to the cleaning strategy, changes to the existing manufacturing process, cleaning procedure or analytical test method, or non-conformances to the existing cleaning procedure.
Teaching objectives for this presentation include: