Packaging Validation

Validate the methodologies and processes applied to package biopharmaceutical products to maintain quality standards and regulatory compliance



Competency Area

Quality Assurance


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