Validation Principles

Aims:
This subject aims to introduce students to the validation principles covered in PIC/S, ICH, EU & FDA cGMPs.

Outline Syllabus: 

• The development of regulatory requirements for validation.
• The V model approach to validation documentation
• Risk Analysis Techniques: Impact Assessment; Failure Mode and Effects Analysis (FMEA)
• Validation Master Plans.
• Commissioning and Qualification (IQ and OQ Validation)
• Process Validation
• Routine validation and revalidation.
• Describe the requirements for annual product reviews.

Learning Outcomes:
On successful completion of this module, the student will be able to:

(1) Knowledge and Understanding

• Describe the development of regulatory requirements for validation.
• List important regulatory guidance documents.
• Describe the V model approach to validation documentation
• Describe the role and purpose of validation master plans.
• Define validation terminology; compare and contrast Commissioning and Qualification.
• State the factors that can impact the commissioning and qualification process.
• Describe a risk based approach for identifying validation requirements and discuss the implications for the product
• Discuss the requirements for routine validation and revalidation.
• Describe the requirements for annual product reviews.
• State differences - retrospective review & re-validation.

(2) Discipline skills

• Understan Validation Master Plans.
• Understand IQ and OQ Protocols.
• Understand impact and criticality assessments.
• Understand process validation protocols.
• Understand a retrospective validation protocol.