PTI - international

VI. Analyze Packaging Operations

• Evaluate packaging of intermediate and bulk product
• Translate clinical protocol requirements into packaged and labeled products
• Analyze storage, labeling and dispensing
• Ensure compliance with test requirements

VII. Examine Production and Quality Control

• Ensure proper identification and labeling for all materials, containers and equipment
• Implement proper security and entrance restrictions where clinical supplies are prepared
• Establish special precautions when using dry materials and products

Exercise: Prepare for Manufacture of Phase II (Open Study) Clinical Supplies

VIII. Prevent Cross-Contamination and Bacterial Contamination

• Provide appropriate segregated areas
• Minimize risk of contamination
• Establish cleaning and decontamination procedures
• Ensure that routine testing is compliant

Exercise: Prepare for Phase II (Double Blind vs. Placebo) Supplies

IX. Comply with GMPs for Process Controls

• Define analytical laboratory requirements and controls
• Validate analytical test methods
• Comply with batch record requirements
• Comply with scale-up requirements

Exercise: Prepare for Phase III Supplies (Double Blind vs.Two Comparators)

X. Outline Documentation Fundamentals

• Ensure proper documentation from receipt of raw materials to manufacturing and labeling of final product
• Develop compliant validation plans for biological processes
• Evaluate OOS results
• Implement GMP training and standard policies
• Analyze EU labeling requirements for clinical material

Exercise: Prepare for Validation Batches

Exercise: Prepare for Line Extension Manufacture