96134 Validation Principles and Practices
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Subject handbook information prior to 2024 is available in the Archives.
Credit points: 6 cp
Result type: Grade and marks
There are course requisites for this subject. See access conditions.
Description
Knowledge, understanding and application of the regulations, processes and strategies for validation in manufacturing operations is critical for implementing good manufacturing practice (GMP). Validation principles for current good manufacturing practices (cGMPs) are introduced, and students examine the validation requirements of various pharmaceutical regulatory bodies and international organisations, including the Therapeutic Goods Administration (TGA) of Australia, the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Pharmaceutical Inspection Co-operation Scheme (PIC/S), and the International Conference on Harmonisation (ICH). Students extend the principles of validation to practical outcomes encompassing practical workshops in preparing validation protocols from planning, through equipment qualification to process validation, evaluation of validation results and how to conduct cleaning validation.
Subject learning objectives (SLOs)
| 008. | Demonstrate awareness and understanding of the requirements for validation through exploration of different regulatory environments |
|---|---|
| 010. | Evaluate, implement and validate production controls |
| 011. | Apply the V-model to validation planning and implementation |
| 012. | Devise appropriate validation strategies for selected manufacturing operations and processes |
| 013. | Prepare validation plans and protocols for equipment/facility qualification and manufacturing processes |
| 096. | Assess requirements and evaluate validation plans and protocols for any stage of validation |
| 098. | Develop and defend cleaning validation programs |
Course intended learning outcomes (CILOs)
The learning outcomes for this subject are as follows:
- Reflect on the knowledge, skills and attributes required for the evaluation and integration of emerging evidence into practice, promoting the growth of personal and professional learning, and the education of others. (01.09)
- Test, audit and validate pharmaceuticals manufacturing and distribution processes using appropriate methodologies. (02.02)
- Demonstrate ethically and legally accountable approaches to pharmaceuticals manufacturing and control. (02.04)
- Analyse and synthesise knowledge of relevant concepts and theory, and apply skills of scientific research and reasoning to support Good Manufacturing Practice. (02.05)
- Produce accurate technical documentation, and communicate effectively and accurately with clients and stakeholders in written or spoken language appropriate to their needs. (02.06)
- Contribute as leader and collaborator in the assurance of Good Manufacturing Practice. (02.08)
- Collaborate effectively with other professions to ensure Good Manufacturing Practice. (02.10)
- Demonstrate knowledge of Good Manufacturing Practice in local, national and global contexts. (03.11)
- Demonstrate respect and value for diverse ways of knowing, being and doing, in particular recognising the diversity of Indigenous Australians, while critically reflecting on the impact of ongoing colonisation and its pervasive discourse on their health and wellbeing, and integrating this knowledge into practice (04.07)
Contribution to the development of graduate attributes
Lifelong learning
Graduates of the Master of Good Manufacturing Practice are lifelong learners, committed to and capable of reflection and inquiry in their quest for personal development and excellence in professional practice.
Professional capacity
Graduates of the Master of Good Manufacturing Practice are quality-focussed, ethical professionals with the understanding and proficiency to be leaders in their profession, capable of effectively researching and communicating solutions in a global context.
Global citizenship
Graduates of the Master of Good Manufacturing Practice contribute to society, resolving to undertake those actions and responsibilities that will enhance their role in local, national and global communities.
Cultural competence
Graduates of the Master of Good Manufacturing Practice are culturally competent professionals, able to reflect on and explain their own cultural perspectives, accommodate cultural differences and achieve optimal outcomes through the adoption of a consultative approach to health care with indigenous Australians and other cultural groups.
Teaching and learning strategies
On campus (standard) mode: This subject will be delivered on the City campus and requires attendance for three hours of face-to-face contact per week, as well as approximately 1-3 hours of personal study pre-work before each class. However, should restrictions related to COVID-19 require it, classes for this subject will be conducted online. The format and content of online classes (should they be required) will be equivalent to face to face on-campus classes and the same attendance requirements apply.
Online (distance) mode: This subject is delivered online via Canvas. Students are required to contribute to weekly discussions as well as participate in occasional online meetings via zoom when required. Students should dedicate approximately 3-6 hours of time to this subject per week.
Students will learn in this Subject through online content comprising videos, set reading, directed research, activities online discussions and self-check quizzes. This independent learning will be supported by group learning experiences, in which ideas and concepts can be tested and refined
Strategy 1: Student directed learning: Students read articles and use online resources, such as online course material, videos, directed research, activities, self-check quizzes and case studies, provided via Canvas. This learning prepares students for their participation in activities that may include facilitated discussion of fundamental concepts drawn from course materials and solutions to industry case studies, assessable quizzes or activities as well as collaborative and interactive learning experiences.
Strategy 2: Collaborative and interactive learning experiences: Provide the students with the opportunity to engage with Peers and Academics to discuss and clarify concepts for a deeper understanding of online course materials.
- On campus students - engage in a weekly 3 hour workshop. Each workshop aims to apply online course materials to real life pharmaceutical industry scenarios through discussions and problem solving in collaboration with fellow students.
- Online students – engage in weekly discussion forums. Each online discussion aims to apply course material in real life pharmaceutical industry scenarios and collaboration with fellow students is required by posting and responding to other students posts in the discussion forum. Students participate in the online discussions by writing their comments in the Canvas platform in their own time and also read and respond to posts from peers. Each discussion has an end time designated by which students must have contributed.
Strategy 3: Early and consistent feedback: Early feedback is provided prior to the census date.
- On campus students – receive feedback in workshops or via the Canvas platform for activities. Feedback regarding the quizzes is provided following each quiz, via provision of answers and/or in-class review. The collaborative learning approach utilised in class will enable ongoing feedback to be provided in class, as areas of learning need are identified through class discussions.
- Online students – receive feedback during ‘open office’ hours and discussion forums. Feedback regarding the self-check quizzes is provided via Canvas immediately upon submission of each quiz. The collaborative learning approach will enable ongoing feedback to be provided to students, via teacher responses to posts, as areas of learning need are identified through online discussions.
Strategy 4: Group work: students work in groups during collaborative and interactive experiences as well as an assessment. Students will need to coordinate group work, fostering negotiation, team building and teamwork skills. Students will need to demonstrate the ability to respond respectfully and constructively to their peers, fostering communication, constructive criticism and respect for diverse ways of working.
Strategy 5: Students are encouraged to critically reflect on their learning throughout the subject to identify areas where they may improve their performance and develop lifelong learning skills.
Content (topics)
The course will be delivered in 6 modules.
Module 1: Validation Principles - Including international regulations and guidance, and validation master plans
Module 2: Equipment/Facility Qualification – User Requirement Specifications
Module 3: Equipment/Facility Qualification - Installation Qualification
Module 4: Equipment/Facility Qualification – Operation Qualification and Performance Qualification
Module 5: Process Validation
Module 6: Cleaning Validation
Assessment
Assessment task 1: On-going Graded Assessment
| Intent: | Throughout the semester you will have the opportunity to check your understanding of the course content via graded assessments through the Canvas platform. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 008, 010, 011, 012, 096 and 098 This task is aligned with the following course learning outcomes: 01.09, 02.02, 02.04, 02.05 and 03.11 |
| Groupwork: | Individual |
| Weight: | 15% |
| Criteria: | Tasks are marked online or by the teacher according to the specific requirements of each task. The tasks are designed to allow assessment of the student’s ability to apply and evaluate the principles taught. A Rubric for assessment of online discussions is available in Canvas. |
Assessment task 2: Facility and Equipment Validation Plan
| Intent: | Validation Project Plans are a mainstay of GMP compliance and often reviewed by regulatory inspectors. The ability to prepare a plan for facilities and equipment is critical to success of the project and the state of compliance for the organisation implementing it. This assessment allows you to demonstrate your understanding of how validation principles are applied in a case that represents a pharmaceutical industry scenario. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 008, 011, 012, 013 and 096 This task is aligned with the following course learning outcomes: 01.09, 02.02, 02.04, 02.05, 02.06 and 03.11 |
| Type: | Project |
| Groupwork: | Individual |
| Weight: | 25% |
| Length: | 1500 words +/- 10% (excluding references) |
| Criteria: | Provided by Canvas |
Assessment task 3: Validation Protocol: Equipment Qualification
| Intent: | This assessment provides students with the opportunity to assess requirements and prepare industry standard validation protocol(s) for equipment used in the pharmaceutical industry. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 008, 011, 013 and 096 This task is aligned with the following course learning outcomes: 02.02, 02.05, 02.06 and 03.11 |
| Type: | Project |
| Groupwork: | Individual |
| Weight: | 30% |
| Length: | Approximately 1500 words |
| Criteria: | Provided via Canvas |
Assessment task 4: Process Validation Presentation
| Intent: | Students are part of a group assessing provided validation data from the point of view of their allocated position (e.g. Production Manager/ QA Manager). The collaborative nature of this assessment allows for development of group membership and leadership skills. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 008, 010, 012 and 096 This task is aligned with the following course learning outcomes: 02.02, 02.04, 02.08, 02.10, 03.11 and 04.07 |
| Type: | Presentation |
| Groupwork: | Group, individually assessed |
| Weight: | 30% |
| Length: | Presentation of not more than 30 minutes On Campus students - present in class Online students - present via zoom |
| Criteria: | Provided via Canvas |
Minimum requirements
On Campus Mode
In order to pass this Subject, a minimum grade of 50% must be achieved.
Students are required to attend a minimum of 85% of classes, and submit all assessment tasks
Online Mode
In order to pass this Subject, a minimum grade of 50% must be achieved and students must submit all assessment tasks.
Required texts
Provided via the subject Canvas site:
Coursework Assessments Procedures
Graduate School of Health Policy, Guidelines and Procedures (login required)
Recommended texts
The following material is mandatory for this subject and is freely available through the internet.
- PE 009: PIC/S Guide to Good Manufacturing Practices: Annex 15
- PI 006-3: PIC/S Recommendations on Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation 2007
- FDA Guidance for Industry: Process Validation: General Principles and Practices January 2011
- EMA Guidance On Process Validation for Finished Products 2016
- PI 009-3 PIC/S – Aide-Memoire - Inspection of Utilities 2007
The following material will aid in the student’s understanding of this subject.
- Relevant Codes of GMP PIC/S; FDA 21CFR series: 211, 820
- FDA Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations Sept 2006
- ICH Q9: Quality Risk Management
- ICH Q8: Pharmaceutical Development
- ICH Q10: Pharmaceutical Quality Systems