Qualification and Validation in Pharmaceutical Manufacturing
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Qualification and Validation in Pharmaceutical Manufacturing

Overview

This training provides a comprehensive understanding of qualification and validation principles within the pharmaceutical industry.
Participants will learn the stages and documentation required to ensure that equipment, systems, facilities, and processes consistently operate in compliance with GMP standards.
The course emphasizes the relationship between qualification (IQ, OQ, PQ) and process validation, as well as how to design an effective validation master plan (VMP) in line with EU GMP Annex 15 and WHO guidelines.

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Outline

  • Introduction to Qualification and Validation – Key concepts and objectives

  • Regulatory Framework – EU GMP Annex 15 and WHO guidelines

  • Qualification Stages – DQ, IQ, OQ, PQ explained

  • Process Validation – Principles and life-cycle approach

  • Validation Master Plan (VMP) – Structure and implementation

  • Requalification and Revalidation – Maintaining compliance

  • Documentation and Audit Readiness – Common challenges and solutions

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