PTI - international

• Define regulatory requirements stated in 21 CFR 211.180(e)
• Interpret the FDA's expectations
• Examine the purpose of APRs and their relationship to other quality system components
• Identify the European Union (EU) requirements for Product Quality Reviews

Discussion: Review Participants' Backgrounds and Experiences with APRs

II. Define Roles and Responsibilities

• Outline who is responsible for what
• Optimize communication among all personnel involved in APRs
• Obtain commitment from management
• Establish timelines for APR preparation and completion

III. Develop and/or Refine Standard Operating Procedures (SOPs)

• List common elements of effective SOPs
• Utilize proven SOP writing techniques
• Evaluate existing SOPs and identify opportunities for improvement

IV. Evaluate Need for Change and Confirm Change Control System

• Assess and amend product specifications
• Evaluate the need for revalidation
• Confirm change control

Exercise: Input to be Included in an Annual Product Review

V. Include Sufficient Batch Data

• Determine the minimum amount of data that is representative
• Incorporate appropriate trending and validation data
• Discern additional information to include that is not required
• Document resulting actions and outcomes

Exercise: Establish a Checklist of Information to Include for Batches

VI. Examine Complaints, Recalls, Returned or Salvaged Drug Products and Investigations Data

• Decide what data to include for this section
• Determine the minimum amount of detail required
• Include sufficient trending data
• Evaluate additional information typically included
• Include all corrective actions

Exercise: Critique a Case Study and Discuss Preventive Measures