University of Technology Sydney

96063 GxP and Quality Auditing Practices

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 subject gives students an advanced understanding of quality auditing practices and is relevant to all disciplines of GxP. This subject provides students with knowledge, and practical skills in auditing principles and practices. It also develops practical skills in planning, conducting and reporting quality audits applicable to the manufacturing of medicines and medical devices.

Subject learning objectives (SLOs)

071. Communicate and prepare reports appropriate to client needs
072. Evaluate available models for post-audit actions using risk-management principles
073. Explain the features and strengths of quality audit processes, and assess their role in GxP compliance
074. Identify and address gaps in quality management for selected manufacturing operations
075. Implement Good Manufacturing Practice (GMP) assessment protocols in compliance with applicable guidelines, statutory regulations and relevant codes of practice through case studies
076. Outline the relationship between audit standards and audit checklists, and identify processes for ensuring that standards are met
077. Prioritise audit requirements based on product and process risks
078. Review the role of audits and risk management assessments in supplier assurance and qualification

Course intended learning outcomes (CILOs)

The learning outcomes for this subject are as follows:

  • 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)
  • 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)
  • Demonstrate knowledge of Good Manufacturing Practice in local, national and global contexts. (03.11)

Contribution to the development of graduate attributes

GxP and Quality Auditing Practices are an essential part of compliance within pharmaceutical manufacturing. Students become familiar with the knowledge of audits and their role in maintaining compliance within the regulated pharmaceutical industry.

Thus in 96063 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 and industry guidance on GMP audits in the pharmaceutical and medical device industry. With a fundamental understanding of the requirements and responsibilities of audits, this subject will elaborate on the compliance of GMP through quality audits in the manufacture of pharmaceutical products. Specifically, students will follow a top-down process from planning to implementation of Corrective and Preventative Action (CAPA) and change control for audit observations / deficiencies using risk management principles to prioritise actions. Students will learn the key successful factors as an auditee when audited by regulatory authorities and as an auditor when auditing vendors and suppliers.

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.

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 GMP quality audits, you will initially learn about the preparation and planning for audits and the regulatory requirements and guidances to follow. Students will apply risk management to assess audits in terms of types of pharmaceutical products produced and supplier assurance and qualification needed. Students will develop communication skills and prepare reports appropriate to client needs. Gaps in quality management, when discovered in audits, will be addressed in proven, effective actions.

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:

071, 072, 073, 074, 075, 076, 077 and 078

This task is aligned with the following course learning outcomes:

02.01, 02.02, 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: Audit Plan in a Simulated Pharmaceutical Setting

Intent:

This assignment is designed to provide a practical approach for you to experience how an audit in a pharmaceutical manufacturing environment should be conducted. You will show your understanding through the preparation of a detailed plan by focusing on a particular system, area or process chosen.

Objective(s):

This task is aligned with the following subject learning objectives:

073, 074, 076 and 077

This task is aligned with the following course learning outcomes:

02.01, 02.06 and 03.11

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

Recommended length 4-5 pages.

Criteria:

Provided via Canvas platform in the Assignments menu.

Assessment task 3: Mock Audit - A Case Study of a Regulatory Audit

Intent:

This assignment provides an opportunity for you to work in a team environment to plan, prepare and conduct a realistic audit. The experience gained is not only limited to GMP audit, but extends to allowing you to work together with peers in interactive team dynamics. You will show deeper understanding about audit in your role play functions.

Objective(s):

This task is aligned with the following subject learning objectives:

071, 072, 074, 077 and 078

This task is aligned with the following course learning outcomes:

02.05, 02.06, 02.08 and 03.11

Type: Presentation
Groupwork: Group, individually assessed
Weight: 30%
Length:

Part 1: Role-play presentation of audit execution: 15 – 20 minutes

Part 2: Written audit report: 5-pages

Criteria:

Provided via Canvas

Assessment task 4: Final Examination

Intent:

This final exam will require you to show your knowledge for this subject through the application of risk assessment in audits and the impacts on processes and products. You will demonstrate your understanding of (i) guidelines and regulations required for auditing in GMP and (ii) implementation of processes and procedures to address the gaps in quality audit management.

Objective(s):

This task is aligned with the following subject learning objectives:

071, 072, 073, 074, 075, 076, 077 and 078

This task is aligned with the following course learning outcomes:

02.01, 02.02, 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 Canvas site.

Coursework Assessments Policy

Coursework Assessments Procedures

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

Recommended texts

The PIC/s Code of GMP, Annex 1

Other relevant references as identified throughout course notes and workshops.