Validation Principles

Aims and Objectives

This subject aims to introduce students to the validation principles covered in PIC/S, ICH, EU & FDA cGMPs. The subject covers Validation Principles & International Regulations, Validation Master Plans and IQ/OQ/PQ Protocol Structure, Process Validation, Statistical Process Control & Retrospective Validation.

On completion of this subject students will be able to:

• State the purpose and scope of validation
• Locate and interpret regulatory guidance.
• Prepare and interpret validation master plans (VMPs)
• Develop IQ and OQ protocols for critical equipment and services.
• Identify requirements for validation of critical process steps
• List what should be covered in process validation protocols.
• Utilise basic statistical techniques to conduct retrospective reviews of existing production processes and products.

Content

This subject consists of 5 modules or topics:

#1 Validation Principles & International Regulations

• This module introduces students to the purpose and scope of validation as well as introducing regulatory guidance.
• State the reasons for validation.
• Describe the development of validation and regulatory control.
• List the scope of validation.
• Describe the V model approach to validation documentation.
• State the definitions of some important validation terms.
• List important regulatory guidance documents.
• Describe the difference between critical and non-critical items.

#2 Validation Master Plans and Protocol Structure

• This module covers how to prepare and understand validation master plans (VMPs)
• Describe the GMP requirements for preparing validation master plans.
• Structure of a VMP and examples of schedules, scope of work & VMP sections.
• Prepare VMPs.
• Understand prospective and retrospective VMPs.

#3 IQ/OQ Protocols & Commissioning

• This module provides information on how to develop IQ and OQ protocols for critical equipment and services. Module outcomes statement:
• Define Installation (IQ) &Operational Qualification (OQ).
• List critical items required to be qualified under GMP.
• Define differences between Qualification & Commissioning.
• Prepare IQ and OQ Protocols.

#4 Process Validation

• This module develops the requirements for validation of critical process steps and provides insight into what should be covered in process validation protocols.
• State regulatory/scientific reasons for process validation.
• Prepare process validation protocols.
• Apply risk management to selecting validation targets.
• Prepare practical and well designed experimental plans.
• List some of the critical steps requiring validation for topicals, liquids and tablets etc

#5 Statistical Process Control & Retrospective Validation

• This module introduces the participants to basic statistical techniques to conduct retrospective reviews of existing production processes and products (annual product reviews).
• Describe Regulatory & QA requirements for periodic reviews of processes and products.
• Describe the requirements for annual product reviews.
• State differences - retrospective review & re-validation.
• Prepare a retrospective validation protocol.
• Use control charts and capability analysis for annual reviews.