1 Semester

30 Hours

External Venue, Hawthorn

Nil, however a basic understanding of, GMP and practical work experience within the industry is assumed. Completion, or co-completion, of HES6401and HES6402 is therefore desirable.

Credit Points: 12.5 Credit Points

Related Course/s:

A unit of study in the Graduate Certificate of Science (Good Manufacturing Practices), and a compulsory unit in the Graduate Diploma of Science (Good Manufacturing Practices), Master of Science (Good Manufacturing Practices) and  Master of Science (Good Manufacturing Practices and Quality Management)

Aims & Objectives:

This unit of study aims to introduce students to the validation principles covered in PIC/S, ICH, EU & FDA cGMPs. At the end of this unit students will be able to:

Validation Principles & International Regulations

• 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.

Validation Master Plans & Protocol Structure

• Describe the GMP requirements for preparing validation master plans.
• Suggest the structure of a VMP and examples of schedules, scope of work & VMP sections.
• Prepare VMPs.
• Understand prospective and retrospective VMPs.

IQ/OQ Protocols & Commissioning

• 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.

Process Validation

• 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….

Statistical Process Control & Retrospective Validation

• 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.

Teaching Methods:

Lectures/Tutorials, Laboratory and/or experiential off-campus learning, Case studies based on actual events that have occurred in the pharmaceutical and related industries will be used, Web Based Unit Presence (Blackboard).

Assessment:

Test 10%, Assignments 50%, Exam 40% 

Generic Skills Outcomes:

Students are expected to enhance several of their graduate attributes during this unit of study and should consult with your lecturer if not clear as to how this unit achieves this. The graduate attributes which relate to this unit help to produce students who:

• Are capable in their chosen professional, vocational or study areas.
• Are entrepreneurial in contributing to innovation and development within their business, workplace, or community.
• Operate effectively and ethically in work and community situations.
• Are adaptable and manage change.
• Are aware of environments in which they will be contributing.

Content:

Validation Principles & International Regulations:
This module introduces students to the purpose and scope of validation as well as introducing regulatory guidance.

Validation Master Plans and Protocol Structure:
This module covers how to prepare and understand validation master plans (VMPs).

IQ/OQ Protocols & Commissioning:
This module provides information on how to develop IQ and OQ protocols for critical equipment and services.

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.

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).

Reading Materials:

A comprehensive Validation Reference Manual with detailed notes
Industry Guidelines on Validation
Case Study and Workshop materials
Other reading materials: Lecture notes (provided via Blackboard)