PTI - international

I. Comply with Regulatory Requirements for Batch Record Reviews

• Analyze GMP requirements for batch records
• Examine 21 CFR 211
• Comply with FDA regulations
• Examine packaging and labeling compliance issues

Discussion: Determine Participants' Backgrounds and Experiences with Batch Record Reviews

II. Examine the Master Batch Record

• Identify the stages of development
• Outline changes in batch size (scale-up/scale-down)
• Describe the relationship between R&D, validation and the Master Batch Record

Exercise: Analyze Record for Common Data Problems and Master Record Development Omissions

III. Explain the Batch Record Review Process

• Examine performance goals
• Use practical skills to ensure an effective review
• Identify roles and responsibilities of those involved with batch record reviews
• Identify discrepancies and preventive action

IV. Prepare for a Batch Record Review

• Examine aspects of properly established SOPs
• Identify process and analytical data
• Establish format for all entries, attachments and reference material
• Ensure correct reconciliation and disposition
• Assess the impact of industry change on batch record reviews

Exercise: Develop a List of Tools and Documents Needed for Batch Record Review

V. Implement FDA and cGMP Requirements for APIs and Excipients

• Examine requirements for production
• Comply with QA/QC requirements
• Identify scale-up issues in cGMP inspections

Exercise: Review Sample 483s to Extract Common Trigger Points