University of Technology Sydney

96057 GMP for Manufacturing 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 2020 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 (C04301) (GMP). This subject provides an overview of manufacturing and packaging operations, risk management, risk assessment and their application in improving decision making processes and optimising good manufacturing practice (GMP) compliance. The subject explores the roles and responsibilities of managers and supervisors in a pharmaceutical manufacturing environment. The contribution of systematic competency-based training is examined.

Subject learning objectives (SLOs)

001. Assess the design and effectiveness of GMP documentation against regulatory standards and guidelines
002. Explain and apply GMP and Quality Assurance requirements to specific manufacturing and packaging operations
003. Develop an action plan and/or a recommendations report and be able to defend and justify your decisions to colleagues and/or managers
004. Explain the principles and major concepts in risk assessment
005. Apply statistical process control techniques to manufacturing processes
006. Examine the ways in which personnel can influence and improve GMP behaviours
007. Generate ideas and contributions within a group dynamic, demonstrating effective communication and collaboration

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)
  • Demonstrate ethically and legally accountable approaches to pharmaceuticals manufacturing and control. (02.04)
  • 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)
  • 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

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

This subject contributes towards developing the following 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.

Teaching and learning strategies

On campus (standard) mode: This subject is 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 pre-work before each workshop.

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 together during collaborative and interactive experiences. Students will need to develop negotiation and teamwork skills, demonstrating 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.

Amendment to On-Campus (Standard) mode

Contact meetings for this subject will now be conducted online only from 18th March. There will be no face-to-face or on-campus classes for this subject. Online meetings via video conferencing will be conducted each week comprising small group workshops to learn the application of class materials. The format and content of these classes will be equivalent to face to face on-campus classes. Students are expected to complete personal study via the Canvas platform each week as preparation for class. It is expected that all students participate in the set activities during the scheduled time-slot for class. Attendance rolls will be marked.

Content (topics)

This subject gives students an insight into practical factory application of GMP, from manufacture and packaging of pharmaceutical products, to APIs and Biotech.

Module 1: Manufacturing
How to ensure that pharmaceutical manufacturing is carried out in appropriately designed, qualified and maintained
facilities including materials and manufacturing controls.

Module 2: Packaging and Labelling

Applying GMP to packaging and labelling operations including printed material control, sampling and reconciliation

Module 3: Personnel

Explore the concepts and practical aspects of a supervisor’s role in influencing GMP compliance through leadership,
training and problem-solving.

Module 4: Risk Management

Explore key concepts of risk in ICH guidance and how risk management practices support compliance programs

Module 5: Statistical Process Control

Implement and interpret the application of statistics to manufacturing process controls

Module 6: Applications

Build on the foundations from modules 1-5, applying them to the manufacture of Active Pharmaceutical Ingredients (APIs). Then further expand these foundations to learn about GMPs adapted to biotechnology products covering establishment and control of cell banks and seed stock, process stages such as purification and special requirements for bioburden and endotoxin control.

Assessment

Assessment task 1: On-going Graded Assessment

Intent:

This assessment task provides students with the opportunity to test their understanding of the course content through online discussions and receive ongoing formative feedback from their peers and teacher.

Objective(s):

This task is aligned with the following subject learning objectives:

001, 002, 003, 004, 005, 006 and 007

This task is aligned with the following course learning outcomes:

02.01, 02.04, 02.06, 02.08, 03.11 and 04.07

Groupwork: Individual
Weight: 15%
Criteria:

Posts will be assessed against four criteria: including and applying relevant course concepts; responding to fellow learners; applying relevant professional, personal or other real-world experiences; supporting position with applicable resources. A rubric for assessment of online discussions is available in Canvas.

Assessment task 2: Report and Oral Defence

Intent:

The ability to investigate and address GMP deficiencies at a technical level, and defend your work is a foundational skill required for industry practice. This assessment provides you the opportunity to demonstrate your understanding of how to deal with GMP issues and practice your communication skills in an industrial scenario based setting.

Objective(s):

This task is aligned with the following subject learning objectives:

001, 002 and 003

This task is aligned with the following course learning outcomes:

02.04, 02.06, 02.08 and 03.11

Type: Report
Groupwork: Individual
Weight: 40%
Length:

Part A Report: 1000 words; Part B Report: 1500 words; Oral Defence: 15 min

Criteria:

Please refer to Canvas for assessment criteria.

Assessment task 3: Video

Intent:

This provides you the opportunity to demonstrate how you would influence the GMP behaviours of manufacturing operators via an educational video.

Objective(s):

This task is aligned with the following subject learning objectives:

006 and 007

This task is aligned with the following course learning outcomes:

02.04, 02.08 and 03.11

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

3-5 minutes

Criteria:

Available on Canvas

Assessment task 4: Final Online Exam

Intent:

This provides you the opportunity to demonstrate how you would detail GMP-compliant implementation approaches to directly address GMP requirements.

Objective(s):

This task is aligned with the following subject learning objectives:

001, 002, 004, 005 and 006

This task is aligned with the following course learning outcomes:

02.01, 02.04, 02.06, 02.08, 03.11 and 04.07

Type: Examination
Groupwork: Individual
Weight: 25%
Length:

1 hour

Criteria:

Marks allocated for each question are shown on the exam paper

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

Coursework Assessments Policy

Coursework Assessments Procedures

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

Please refer to the Subject Canvas site

Recommended texts

The PIC/S Code of GMP, which you will use, must be kept for all subjects.

  • PE 009-13 (Part I) PIC/S Guide to Good Manufacturing Practices For Medicinal Products (Part I)*
  • PE 009-13 (Part II) PIC/S Guide to Good Manufacturing Practices For Medicinal Products (Part II)*
  • PE 009-13 (Annexes) PIC/S Guide to Good Manufacturing Practices For Medicinal Products (Annexes)*

Other relevant references are:

ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes

ISO 14971:2012 Medical Devices – Application of Risk Management to Medical Devices

21 CFR Part 211 Good Manufacturing Practice for Finished Pharmaceuticals*

21 CFR Part 600 Biological Products: General*

FDA Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations *

FDA Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance *

FDA Compliance Program Guidance Manual Program 7356.002 Drug Manufacturing Inspections*

ICH Q9: Quality Risk Management*

WHO Quality assurance of pharmaceuticals Volume 2, Good manufacturing practices and inspection *

WHO Guidelines for Sampling of Pharmaceutical and Related Materials *

Items marked with ‘*’ are available online at no charge