Webinar: Analytical Quality Control for the Pharmaceutical Industry

Introduction

• Moderator: Tracy Aston Martin
• Presented by: LabRoots
• Sponsored by: Sartorius
• Speaker: Joy McIlroy, owner and consultant at McIlroy Training and Consultancy LLC

Overview

• Purpose: Discuss processes and importance of Analytical Quality Control (AQC) in pharmaceutical labs
• Focus: Ensuring accuracy, reliability, and safety in lab test results

Importance of Analytical Quality Control

• Detects analytical errors in labs
• Ensures reliability and accuracy of test results
• Prevents release of adulterated products which can be harmful to patients
• Ensures manufacturing of high-quality products

Establishing AQC

• Develop Standard Operating Procedures (SOPs) for lab activities
  • SOPs: Document routine/repetitive activities
  • Include all processes: Equipment operation, maintenance, and calibration
  • Ensure SOPs are adhered to, reviewed, and updated regularly
  • SOPs ensure compliance with regulations (GMP, GLP)

Components of SOPs

• Purpose: Clearly define the objective
• Scope: Specify what the SOP covers
• Responsibilities: Identify who follows and enforces SOP
• Procedures: Detailed step-by-step instructions
• Safety: Guidelines on safe operation
• Training: (Optional) Who should be trained

Analytical Instrument Qualification

• Instruments must be qualified to prove they perform as intended
• Qualification Process:
  • Design Qualification (DQ): Instrument designed to meet specified requirements
  • Installation Qualification (IQ): Correct installation and environment
  • Operational Qualification (OQ): Meets manufacturer specifications
  • Performance Qualification (PQ): Meets routine usage specifications
• Use a risk-based approach to classify instruments (low, medium, high risk)

Risk-Based Approach

• Low Risk Instruments: Simple, no calibration (e.g., vortex mixers)
• Medium Risk Instruments: Measurement capabilities, may require calibration (e.g., balances, thermometers)
• High Risk Instruments: Complex, require full qualification (e.g., HPLCs, freezers)

Re-qualification & Quality Auditing

• Re-qualification: Periodically re-test instruments to ensure continuous performance
  • Critical instruments: Annually
  • Non-critical: Every 3-5 years
• Quality Audits: Regular internal/external reviews to ensure compliance

Audience Q&A Highlights

• User Requirements: Important for complex instruments; less so for simple ones
• Calibration: Depends on instrument type and manufacturer's instructions
• SOP Review Frequency: At least bi-annually
• SOPs in Academic Settings: Necessary if tied to industry projects

Conclusion

• Emphasized importance of documentation in maintaining control and compliance
• All processes should be documented and reviewed regularly to ensure quality and compliance.