Day Two

Validation IQ/OQ/PQ for Packaging and Labeling Equipment

Equipment analysis and verification of function and maintenance standards

Installation Qualifications, Operational Qualifications, and Performance Qualifications

Validation requirements specific to packaging and labeling including security and computerized processes

Standard FDA regulations on equipment validation procedures and processes

Session V

Packaging Component Suppliers

Complying with component regulations

Partnering with component suppliers that meet regulatory standards

Conducting a pre-approval process for suppliers

Determining roles and responsibilities for suppliers Inspecting all components that come in

VI	Product Sampling Discuss Current FDA regulations on sampling Document and monitor sample distribution Sample inspections

Session VII

Packaging Line Challenges

Create clear written instructions for operation and maintenance line procedures

Use of dedicated lines

Monitor printing devices associated with manufacturing lines

Separate labeling and packaging lines

VIII	Packaging Line Clearance Standardize line clearance, inspection and documentation Minimize line contamination Implement a risk management approach to minimize line clearance error Evaluate line clearance audits that will ensure compliance

Session XI

Packaging Equipment Cleaning

Validation techniques and documentation for cleaning and anti-contamination processes

Verify and improve cleaning practices to insure compliance

Address FDA sanctions and equipment guidelines that ensure GMP

X	FDA Inspections of Packaging and Labeling Discuss inspection process Review GMPs and SOPs for the packaging and labeling system Assess impact of an FDA inspection and report Identify best practices in documentation and reporting that will help facilitate the process

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