PTI - international

V. Establish and Confirm the Standard Operating Procedure (SOP)

• Outline roles and responsibilities of validation team members
• Identify documents needed for qualification
• Recognize the key components of commissioning documents
  • Sampling points
  • Frequency
  • Sampling techniques
  • Acceptable sample sizes
• Develop Standard Maintenance Procedures (SMPs)
• Identify the key components of Installation, Operation and Performance
  Qualifications (IQ/OQ/PQ)
• Establish acceptance criteria
• Collect enough data to verify the SOP and evaluate the water system

Exercise: Identify Required Qualification Documents

VI. Document Compliance with Validation Requirements

• Provide an accurate description and print of the water system
• Perform IQ, OQ, PQ
• Perform and document change control
• Write a thorough validation document and obtain approval

Exercise: Build and Document your Water System

VII. Troubleshoot Efficiently and Effectively

• Identify commonly overlooked sources of contamination
• Plan a course of action for when action limits are exceeded
• Outline steps to take when specifications are exceeded

Exercise: Variance and Deviation Investigations

VIII. Comply with 21 CFR Part 11

• Interpret regulatory requirements for e-records and e-signatures and their applicability to
  water systems
• Qualify software used to monitor water systems
• Examine strategies for compliance

IX. Examine Additional FDA Expectations

• Address additional requirements, including:
  • Maintenance logs
  • Qualification and certification of equipment/vendors
  • Reviews and investigations
• Assess the consequences of non-compliance

Exercise: Review Recent 483s and Warning Letters