Fundamentals of Process Validation

Lesson Code: PVF-830. Introduction to validation in regulated industries using case study of tablet manufacturing process. Includes validation masterplan, validation life cycle, specification, qualification and revalidation.

  • Category: Pharma Manufacturing Validation


After taking this e-Lesson, you will be able to:

- Explain the term 'validation' and why it must be performed in regulated industries

- List the five established validation categories

- Explain the risk assessment approach to validation

- Explain the purpose of a Validation Master Plan (VMP) and describe its contents

- Explain the concept of the Validation Life Cycle

- Describe the different stages of the Validation Life Cycle

- Explain 'traceability matrix' and describe its use in validation

- Explain the terms Design Specification (DS), Functional Specification (FS), and User Requirements Specification (URS)

- Explain the purpose of process validation

- Describe each of the four qualification stages: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

- Explain how the qualification stages relate to the equipment specifications

- Explain the concepts of change control, revalidation and decommissioning