Overview of Qualification and Validation

Validation in ongoing process review to ensure that the manufacturing process leads to final products of the desired quality. Validation goes hand-in-hand with documentation and is part of current Good Manufacturing Practice (cGMP) guidelines. This process seeks to ensure that all systems are functioning properly and capable of recreating the target quality. Therefore, validation must be consistently done as long as products are being manufactured. This is an introduction to the concept that covers its history, necessity, and goals. You will also learn about the different kinds of validation and proper documentation.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Introduction

• Validation and GMP Go Hand in Hand!

Lesson 1: Definition of Validation

Lesson 2: Need for Process Qualification and Validation

Lesson 3: Scope of Validation

• Importance of Validation

Lesson 4: Major Advantages of Validation

• Assurance of Quality
• Process Optimization
• Reduction of Quality Costs
• Safety

Lesson 5: Types/Methods of Validation

• Prospective Validation
• Concurrent Validation
• Retrospective Validation
• Revalidation

Lesson 6: Activities to be Undertaken Before Commencing Validation Project

• The Validation Committee
• Process Evaluation to Determine Validation Requirements
• Identification of Systems and System Boundaries

Lesson 7: Validation Master Plan

• Validation Master Plan
• Contents of VMP

Lesson 8: Basic Concept of Process Validation

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Prerequisite of Process Validation
• Reason for Process Validation

Lesson 9: The Stages of Process Validation

• Stage 1 – Process Design
• Stage 2 – Process Validation or Process Qualification
• Stage 3 – Continued Process Verification

Lesson 10: Validation Protocol Report

Lesson 11: Cleaning Validation

• Choice of Cleaning Method
• Measuring the Level of Cleanliness
• Setting Limits

Lesson 12: Computer System Validation

• Assessment of Computer Systems to Determine Validation Requirements
• Hardware
• Software

Lesson 13: Analytical Methods Validation

• Change Control and Revalidation
• Revalidation

Conclusion

Glossary

Quiz