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HES6403 Validation Principles (3 days)

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.

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.

Out of Class Assignment

Participants are offered the opportunity to complete a GMP assignment following completion of the course. This will be facilitated and supported remotely by SeerPharma's team of consultants, and successful completion will be rewarded with additional certification.

There is no additional charge for this.