Cleaning Validation Matrix In Pharmaceutical Industry

From Theory to Practice: Navigating Cleaning Validation in Pharma

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.

Requirements

No experience needed, you will learn everything you want

Description

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.

Overview

Section 1: Introduction

Lecture 1 Brief Introduction to the Course

Section 2: Course: Part 1

Lecture 2 Cleaning Validation Total Equipment Surface Area Calculation Explained

Lecture 3 Foundational Data for Cleaning Validation From PDE to Batch Size

Lecture 4 Why Determine the Worst-Case API Understanding the Objective

Lecture 5 From PDE to Potency Demystifying the Risk Value Concept

Lecture 6 Risk Value Factors Cleanability and Batches per Year in Focus

Lecture 7 Step-by-Step Guide to Calculating the Combination Factor

Section 3: Course: Part 2

Lecture 8 Understanding MACO Why We Calculate It and How Safety Factors & MTD Fit In

Lecture 9 How to Select Minimum Batch Size and Maximum Daily Dose for MACO Calculations

Lecture 10 Cleaning Validation Fundamentals MACO Objective, Swab Surface Area Calculation

Lecture 11 Cleaning Validation Calculation MACO with PDE and 10 ppm

Lecture 12 Cleaning Agent MACO Calculation Using PDE and 10 ppm for Contamination Control

Section 4: Conclusion

Lecture 13 Quick recap for the Course

Pharmacy Students curious to know about the pharmaceutical industry