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.
- Utilize 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.
Format
The course consists of a lively mix of presentations, group exercises, and discussions. At the end of the course, there will be a short quiz to test understanding. Copies of all presentation slides and handouts will be provided.