From Theory to Practice: Navigating Cleaning Validation in Pharma
In the pharmaceutical industry, cleaning validation is crucial to ensure that manufacturing processes do not carry over harmful residues from previous batches, safeguarding product quality and patient safety. This course provides a comprehensive understanding of the Cleaning Validation Matrix, a risk-based approach used to define cleaning requirements and limits for pharmaceutical manufacturing equipment.
What you’ll learn
- Calculation of the Total Surface Area of the whole Manufacturing Line.
- Specification of the data parameters to be collected per API endpoint.
- Methodology for computing the combination factor to identify the worst-case API scenario.
- Determination of the Maximum Allowable Carryover (MACO) based on Permitted Daily Exposure (PDE), dose-based criteria, and the 10 ppm limit..
Course Content
- Introduction –> 1 lecture • 1min.
- Course: Part 1 –> 6 lectures • 13min.
- Course: Part 2 –> 5 lectures • 17min.
- Conclusion –> 1 lecture • 4min.
Requirements
In the pharmaceutical industry, cleaning validation is crucial to ensure that manufacturing processes do not carry over harmful residues from previous batches, safeguarding product quality and patient safety. This course provides a comprehensive understanding of the Cleaning Validation Matrix, a risk-based approach used to define cleaning requirements and limits for pharmaceutical manufacturing equipment.
Through a combination of theoretical knowledge and practical application, this course covers key topics such as:
- Fundamentals of Cleaning Validation: Learn the importance of cleaning validation and regulatory requirements.
- Risk-Based Matrix Approach: Understand how to create and implement a cleaning validation matrix to assess and control contamination risks.
- Key Parameters: Explore the critical parameters used in cleaning validation, such as PDE (Permitted Daily Exposure), MACO (Maximum Allowable Carry-Over), and the Minimum Therapeutic Dose.
- Methods for Validation: Discover how to calculate critical factors for cleaning, including the use of 10 ppm and other methods for validating cleaning processes.
- Documentation and Compliance: Understand the importance of documenting cleaning validation protocols to ensure compliance with industry standards (e.g., FDA, EMA).
- Case Studies and Practical Insights: Analyze real-world examples and case studies to better understand the challenges and solutions in cleaning validation.
By the end of this course, participants will have a solid understanding of how to design and implement a robust cleaning validation matrix, ensuring that pharmaceutical products are manufactured in a safe and compliant environment.