Packaging Validation
Validate the methodologies and processes applied to package biopharmaceutical products to maintain quality standards and regulatory compliance
Type
Functional
Competency Area
Quality Assurance
Levels
Implement validation processes to review the quality of packaging processes
Collect data on critical validation characteristics according to Standard Operating Procedures (SOPs)
Check if packaging materials are kept under proven storage conditions or those specified by suppliers
Verify materials and packaging variables that affect the ability of biopharmaceutical products to meet acceptable requirements
Verify packaging equipment and calibration parameters against validation criteria
Review sampling methods for packaging qualifications
Verify the environment and conditions under which packaging is performed
Analyse measurable acceptance criteria for tests or checks being conducted
Verify that packaging is performed in line with CGMPs procedures and standard protocols
Report packaging validation activities and results
Develop validation processes for the approval of packaging methodologies and processes
Develop packaging validation plans to assure the quality of product packaging
Develop packaging validation Standard Operating Procedures (SOPs)
Introduce technologies to automate or facilitate packaging validation processes
Validate packaging processes against specified product and packaging requirements
Determine final acceptance criteria for all packaging validation exercises
Set and monitor boundary conditions
Define acceptable conditions for carrying out packaging activities and storage of packaging materials
Evaluate the impact of equipment, product, or process changes on packaging effectiveness
Adapt packaging validation procedures to accommodate new equipment, products or manufacturing processes
Communicate key findings from packaging validation results to relevant stakeholders