University of Technology Sydney

96064 Risk Management for Pharmaceutical Operations

Warning: The information on this page is indicative. The subject outline for a particular session, location and mode of offering is the authoritative source of all information about the subject for that offering. Required texts, recommended texts and references in particular are likely to change. Students will be provided with a subject outline once they enrol in the subject.

Subject handbook information prior to 2022 is available in the Archives.

UTS: Health (GEM)
Credit points: 6 cp
Result type: Grade and marks

There are course requisites for this subject. See access conditions.

Description

This is a foundation subject in the Master of Good Manufacturing Practice (GMP). This subject introduces the key principles and functions of compliance for an organisation, describes what a compliance program consists of and how to set up a company program. The subject introduces the key principles and risk models for the introduction of a risk management program into regulated life sciences organisations. The requirements of AS4360 – Risk Management are reviewed. The subject also provides guidance on how risk management practices are used to support compliance programs.

Subject learning objectives (SLOs)

079. Apply appropriate risk evaluation and risk management strategies for GMP compliance
080. Apply given risk management tools to analyse and control risks
081. Conduct risk assessment and control using the principles and theories of risk management to manage risks in selected case studies
082. Evaluate compliance measures against acceptable risk
083. Evaluate the application of risk analysis and risk management to quality management systems and processes
084. Explain Quality by Design – Risk analysis in design and development of products
085. Explain regulatory guidance for applying risk management in pharmaceuticals – FDA, EU/PICs/TGA, ICH
086. Prioritise actions for risk management through qualitative and quantitative evaluation tools

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)
  • Demonstrate accurate and comprehensive knowledge of risk management practices and models, and implement and evaluate them in a range of contexts. (02.01)
  • Test, audit and validate pharmaceuticals manufacturing and distribution processes using appropriate methodologies. (02.02)
  • Design, implement and evaluate control systems for pharmaceuticals manufacturing. (02.03)
  • 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)
  • Demonstrate knowledge of Good Manufacturing Practice in local, national and global contexts. (03.11)

Contribution to the development of graduate attributes

Here students become familiar with the skills and knowledge necessary to apply Risk Management principles to ensure quality manufacturing, packaging and management of pharmaceutical operations.

Thus in 96064 students progress towards achievement of the course's Lifelong Learning, Professional Capacity and Global Citizenship graduate attributes.

Lifelong Learning:

Graduates of the Master of GMP 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 GMP are industry-focused, ethical practitioners with the understanding and proficiency to be leaders in their profession, capable of effectively analysing and implementing solutions in a global context under international regulatory guidelines.

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.

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 and self-check quizzes. This independent learning will be supported by group learning experiences, in which ideas and concepts can be tested and refined. Workshops are held to provide an opportunity to apply online content to simulated real life pharmaceutical industry situations.

Students will start learning about the regulatory requirements for risk management. With a fundamental understanding of risk management principles, this subject will elaborate on the identification, analysis and management of risks in the manufacturing processes to ensure pharmaceutical products that are safe, pure and effective. Specifically, students will follow a top-down process from planning to risk management, using risk management tools such as Hazard Analysis and Critical Control Point (HACCP) and Failure Mode and Effects Analysis (FMEA) to address and control risks. The concept of Quality by Design (QbD) is introduced to emphasise the importance of designing quality into a pharmaceutical product while in the early R&D phases and continue with process improvement as manufacturing knowledge is established.

Strategy 1: Self-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 activities such as quizzes, interactive learning experiences, facilitated discussion of solutions to industry case studies, and collaborative online discussion of fundamental concepts drawn from course material and international regulatory guidelines and practices.

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: Collaborative/ group work:

  • On campus students – work in groups during workshop sessions. Students will need to coordinate group work, fostering negotiation, team building and teamwork skills, and respect for diverse ways of working.
  • Online students –work collaboratively through online discussions. Students will need to respond respectfully and constructively to their peers' posts 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.ed

OPELA (online language screening task)

An aim of this subject is to help you develop academic and professional language and communication skills in order to succeed at university and in the workplace. To determine your current academic language proficiency, if you have never completed the OPELA, or this is your first session at UTS, then you are required to complete an online language screening task, OPELA (information available at https://www.uts.edu.au/research-and-teaching/learning-and-teaching/enhancing/language-and-learning/about-opela-students). If you receive a Basic grade for OPELA, you must attend follow up language development activities in order to pass the subject. These activities are outlined below:

On campus students: You must attend additional Language Development Tutorials (each week from week 3/4 to week 12). These tutorials are designed to support you to develop your language and communication skills. Students who do not complete the OPELA and/or do not attend 80% of the Language Development Tutorials will receive a Fail X grade.

Online students: You must complete additional language development activities during the teaching session. The activities will be made available to you online during the teaching session. These activities are designed to support you to develop your language and communication skills. Students who do not complete the OPELA and/or do not complete 80% of the language activities will receive a Fail X grade.

Content (topics)

Within the broad context of risk management, you will initially learn about the regulatory requirements to ensure pharmaceutical product safety and effectiveness. You will learn about the risk management tools used. Case studies are presented where students develop skills to identify, analyse and control risks. Students also learn to assess and prioritise risk management in accordance with product safety characteristics and process complexities.

Assessment

Assessment task 1: On-going Graded Assessment

Intent:

Throughout the semester student will have the opportunity to check their understanding of the course content via graded assessments through the Canvas platform.

Objective(s):

This task is aligned with the following subject learning objectives:

079, 080, 081, 082, 083, 084, 085 and 086

This task is aligned with the following course learning outcomes:

02.01, 02.02, 02.03, 02.04, 02.05 and 03.11

Groupwork: Individual
Weight: 15%
Criteria:

Tasks are marked by the lecturer 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 learned.

Assessment task 2: Risk Assessment in Pharmaceutical Manufacturing

Intent:

This assignment is designed for you to show how you can apply the risk management tools in GMP. Through this assignment you will experience the importance of evaluating risks in pharmaceutical manufacturing and the implementation of appropriate controls to ensure products are safe, effective and pure.

Objective(s):

This task is aligned with the following subject learning objectives:

079, 080, 081, 083 and 085

This task is aligned with the following course learning outcomes:

01.09, 02.01, 02.03, 02.04, 02.05, 02.06 and 03.11

Type: Report
Groupwork: Individual
Weight: 20%
Length:

Approximately 1500 words, excluding references

Criteria:

Provided via Canvas in the Assignments menu

Assessment task 3: Case Study - Risk Management Assignment

Intent:

This assignment is designed for you to demonstrate further understanding about how to apply risk assessment and management in pharmaceutical design and manufacturing processes. The risk assessment and management aspects extend through the lifecycle of pharmaceutical products. You will show your understanding of the concept of Quality by Design (QbD).

Objective(s):

This task is aligned with the following subject learning objectives:

079, 080, 081, 082, 083, 084, 085 and 086

This task is aligned with the following course learning outcomes:

01.09, 02.01, 02.02, 02.03, 02.04, 02.05, 02.06 and 03.11

Type: Report
Groupwork: Individual
Weight: 30%
Length:

Approximately 1500 words, excluding references

Criteria:

Provided via Canvas in the Assignments menu

Assessment task 4: Final Examination

Intent:

This final exam is for you to show how to analyse risks associated with manufacturing processes, and to overcome these risks through controls and validations. You will demonstrate your knowledge by providing and explaining a risk management master plan for pharmaceutical products.

Objective(s):

This task is aligned with the following subject learning objectives:

079, 080, 081, 082, 083, 084, 085 and 086

This task is aligned with the following course learning outcomes:

01.09, 02.01, 02.02, 02.03, 02.04, 02.05, 02.06 and 03.11

Type: Examination
Groupwork: Individual
Weight: 35%
Length:

1 hour and 40 mins; including 10 minutes of reading time

Criteria:

Provided via Canvas in the Assignments menu

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.

OPELA

It is a requirement of this subject that all students who are in their first session at UTS or have never completed OPELA, must complete OPELA. Students who received a Basic grade in the OPELA are required to attend 80% of the Language Development Tutorials, or, for online students, complete 80% of compulsory language activities in order to pass the subject. Students who do not complete the OPELA and/or do not complete 80% of the Language Development Tutorials or compulsory language activities will receive a Fail X grade.

Required texts

Provided via the Canvas site

Coursework Assessments Policy

Coursework Assessments Procedures

Graduate School of Health Policy, Guidelines and Procedures (login required)

Recommended texts

ICH Q9 – Quality Risk Management

ASTM E55.03 (Draft) (WK9864) Standard Guide for Science and a Risk Based Approach to Qualification of Biopharmaceutical and Pharmaceutical Manufacturing Systems)

EU/PICs/TGA cGMP – Annex 15 Qualification and Validation*

FDA Guidance for Industry Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations*

ICH Q8 – Pharmaceutical Development* ICH Q10 – Quality Management Systems*

ANSI/AAMI/ISO Standard 13485:2003 Medical devices – Quality Management Systems – requirements for regulatory practices

ISO 14971:2000 – Application of Risk Management to Medical Devices

Other relevant references as identified throughout course notes and workshops.