GXP0117 Overview of Qualification and Validation

GXP0117 Overview of Qualification and Validation

Description:

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 hence, 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

Author:

GXP0117 Overview of Qualification and Validation
Amita Joshi
Amita Joshi holds a Doctorate in Pharmaceutical Sciences. She has more than 20 years of experience in pharmaceutical dosage form research in Industry as well as academia. She has been a recipient of prestigious GYTI award by DBT, Govt. of India & SRISTI, India for pharmaceutical technology development for the management of HIV. She has published more than 25 peer-reviewed research publications. Amita Joshi is the founder of Biobay solutions. She is currently engaged in providing pharmaceutical technology solutions and scientific communication.

General info:

Duration:

1 hour

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

Reviews:

This course happened to be the best way to show my team the importance of process validation and documentation. Now, they are armed to maintain product quality and integrity.

Alex S

-

Chief Operations Officer

You want to discover this course ?

GXP0117 Overview of Qualification and Validation

Quote request