Cleaning Validation
Validate processes and methods for achieving required standards of cleanliness
Type
Functional
Competency Area
Quality Assurance
Levels
Implement validation processes to review the quality of cleaning procedures
Collect data on critical validation characteristics
Check that cleaning procedures are performed in line with Standard Operating Procedures (SOPs) and CGMPs
Identify deviations or potential risks in processes used to clean equipment and surfaces
Verify the environmental conditions under which cleaning is carried out
Verify the equipment used to clean or remove contaminants
Verify the quality and quantity of disinfectants, detergents, solvents and other agents used for cleaning
Determine the specificity and sensitivity of methods used to detect residuals or contaminants
Report cleaning validation results
Investigate significant trends or findings from cleaning validation results
Develop validation processes to ensure the effectiveness
Develop cleaning validation plans customised to different biopharmaceutical product requirements
Articulate objectives and indicators of successful cleaning validation
Determine the cleaning methods and processes that require validation
Develop cleaning validation processes for biopharmaceutical manufacturing plants
Establish quality standards and desired outcomes of cleaning validation activities
Manage consistency of cleaning methodologies
Determine final acceptance criteria for all cleaning validation exercises
Define the acceptable range of environmental conditions for cleanrooms and general facilities
Define key accountabilities for the performance of cleaning validation
Present key findings from cleaning validation results to relevant stakeholders