PTI - international

I. Review the Fundamentals of cGMP/QSR Requirements

• Interpret GMP/QSR regulations and current industry standards
• Clarify roles and responsibilities
• Relate GMPs to ICH's harmonization efforts
• Apply GMPs appropriately to combination products

Exercise: Identify Participants' Backgrounds and Course Expectations

II. Understand the FDA's New Risk-Based Approach to GMPs

• Acquire knowledge of risk-based initiative management principles
• Utilize the latest Process Analytical Technology (PAT)
• Identify risk factors considered by FDA when determining who to inspect
• Assess the risk-based initiative's impact on inspections and issuance of warning letters

III. Overcome Common Documentation Obstacles

• Implement documentation requirements for:
  • procedures
  • evidentiary records
  • batch records
  • specifications
  • master records
• Identify authority and criteria for SOPs
• Develop consistent and thorough cGMP/GMP documents
• Establish effective change control

Interactive Discussion: Analyze Specifications vs. SOPs

IV. Evaluate and Improve Manufacturing Processes

• Ensure that effective cleaning techniques are in place
• Provide effective change control techniques and justify changes
• Ensure processing procedures are well-documented and followed

Exercise: Critique a Manufacturing Process Specification

V. Improve Quality Control

• Implement a quality control unit that adequately performs its functions and responsibilities
• Determine and maintain best practices for component control
• Outline in-process functions and ensure quality product release
• Incorporate supplier controls and supplier audit programs
• Comply with stability testing requirements and define responsibilities
• Understand the deviation process and employ meaningful controls
• Develop effective GMP training programs

Discussion: Critique Organizational Responsibilities
Exercise: Count the Gs

VI. Implement Strategies for Process Validation and Instrument Calibration and Qualification

• Understand the distinction between validation, verification and qualification
• Address IQ/OQ/PQ issues
• Identify what needs to validated
• Perform revalidation and partial validations as appropriate
• Determine specific distinctions related to computer validation
• Evaluate validation acceptance criteria

Exercise: Validation Rationale and Principles