To maintain audit and inspection readiness at all times in pharmaceutical industry, following criteria are to be maintained:
1. Clear Communication Channel
- Manufacturing and quality teams should establish clear communication channels.
- Regular meetings and discussions enable both teams to align their objectives, address potential gaps, and share insights
2. Document Control and Management
- Maintaining accurate and up-to-date documentation is essential for audit readiness.
- Manufacturing and quality teams should establish robust document control and management systems. This includes implementing electronic document management software that enables version control, document tracking, and easy retrieval.
3. Effective Training and Competency Programs
- Investing in training and competency programs is important to ensure that employees understand their roles and responsibilities in maintaining audit readiness.
- Manufacturing and quality teams should collaborate to develop comprehensive training programs that cover good manufacturing practices (GMP), SOPs, and regulatory requirements.
- Regular training sessions, refresher courses, and assessments.
- Tracking and maintaining records of employee training completion are essential for audit readiness.
4. Robust Change Control Processes
- To maintain audit readiness, teams must establish robust change control processes. This includes a thorough evaluation of proposed changes, impact assessments, and proper documentation.
- Collaboration between manufacturing and quality teams is essential to assess the potential risks associated with changes, ensuring proper validation and qualification and updating relevant documentation and procedures.
5. Real-time Monitoring and Data Analytics
- Real-time monitoring and data analytics can greatly enhance audit readiness. advanced monitoring systems and data analytics tools, manufacturing and quality teams can proactively identify potential issues, trends, and deviations. -Continuous monitoring of critical parameters, process controls, and quality metrics enables timely corrective actions.
- Empower the teams to work together with other functions, such as process development, to establish better ways of working.
6. A Culture of Continuous Improvement
- Creating a culture of continuous improvement is vital for maintaining audit readiness.
- Encouraging feedback and suggestions from manufacturing and quality teams fosters a proactive mindset.
- Regular reviews of audit findings and corrective actions help identify recurring issues and implement preventive measures.
To do this, create goals for your management team that include assessing their team’s performance by making it easy for them to access the information associated with performance. How? Include names or initials in deviation records, publicly reward those doing the right thing, and conduct mandatory weekly walkthroughs with both manufacturing and Quality.
- FDA Compliance Guide on Pre-approval Inspections (PAI) for Drugs
- Pre-FDA Audit Inspection Day Checklist
Resource Person: Hassan Hussein