Cleaning Validation

Validate processes and methods for achieving required standards of cleanliness



Competency Area

Quality Assurance


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