PTI - international

VI. Implement GMP-Compliant Manufacturing Controls

• Employ production and process controls
• Maintain packaging and labeling controls
• Determine QC strategies for starting and in-process materials
• Manage records and reports
• Define GMP facility operation
  • cleaning and maintenance

Exercise: Case Study

VII. Maintain GMP Compliance for Storage and Distribution Operations

• Determine requirements for holding and distribution
• Identify how to handle returned goods
• Establish methods and procedures for handling
• Put controls in place to prevent mix-ups
• Identify which records and reports to maintain and determine for how long

VIII. Apply Fundamentals of Validation to GMPs

• Define validation and validation protocols
• Perform process validation and test method validation
• Define GMP validation requirements
• Determine what to validate
• Identify impact on GMP elements

Exercise: Critique GMP Validation Methods

IX. Identify Current Regulatory Enforcement Trends

• Determine requirements for efficient CAPA
• Determine what triggers an inspection
• Analyze the FDA's new risk-based approach to inspecting drug manufacturers
• Understand the inspection process and potential enforcement actions