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96065 Process Development for Therapeutics: A Perspective for Finished Dose Forms

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

Solid and topical semisolids, such as tablets and creams respectively, are common dose forms produced in the pharmaceutical industry. This subject guides students through the manufacturing process of common dose forms, from required starting materials through to formulation, steps in manufacturing and final product packaging. Students develop an understanding of how full-scale manufacturing technologies function, as well as the strategic skills required for process optimisation and validation. The impact of quality assurance on finished dose forms and the importance of quality management are also studied.

Subject learning objectives (SLOs)

030. Explain the manufacturing principles behind oral solid dose, oral liquid dose and topical preparations
031. Select and justify appropriate equipment design, process control plans and validation strategies for a given finished pharmaceutical dose form
032. Identify and maintain appropriate risk management strategies for GMP compliance for the manufacturing of a finished pharmaceutical dose form
033. Explain and justify the use and impact of various excipients used in selected finished pharmaceutical dose forms
034. Assess site production requirements and contrast the capabilities / limitations of required manufacturing equipment for the creation of finished dose forms
035. Implement appropriate quality control tests and acceptance criteria for relevant production equipment and finished dose forms 

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)
  • 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)

Contribution to the development of graduate attributes

This Subject highlights the necessity for quality assurance, good manufacturing practice, good laboratory practice and quality control in the pharmaceutical industry.

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.

Teaching and learning strategies

Lectures and workshops will provide relevant knowledge and theoretical underpinnings. Lectures and workshops are both face to face. Workshops provide an opportunity to apply lecture content to simulated real life pharmaceutical industry situations.

Strategy 1: Student preparation for learning: Students read articles and news items, watch videos relevant to process development, follow regulatory updates and notices as well as use of online resources, such as online lecture notes and case studies provided via Canvas. Students prepare for their participation in activities including facilitated discussion of solutions to industry case studies, class quizzes, and collaborative discussion of fundamental concepts drawn from lectures and international regulatory guidelines and practices.

Strategy 2: Active lectures: Lectures are a key learning resource in this subject. Attending lectures is crucial to a full understanding of the subject content. The lectures will involve collaborative questions and class discussions of the pertinent points. These questions will help to keep students engaged throughout the session. There will be 1 hour of lecture each week. Notes corresponding with each lecture are uploaded to Canvas.

Strategy 3: Collaborative and interactive learning in workshops: Workshops provide students with an opportunity to discuss and clarify concepts from the lectures, thus providing the students the opportunity for deeper understanding. Each workshop aims to apply lecture contents in real life pharmaceutical industry scenarios and collaboration with fellow students is encouraged. Students will engage in group discussions and problem solving. There will be 2 hours of workshop each week.

Strategy 4: Early and consistent feedback: Early feedback is provided face to face prior to the census date during lectures and workshops. Feedback regarding the quizzes is provided following each quiz, and also individually during workshop discussions. The collaborative learning approach utilised in class will enable ongoing feedback to be provided either in class or online, as areas of learning need are identified through class discussions.

Strategy 5: Group work: students work in groups on their group assignment, and workshop sessions. Students will need to coordinate group work and meetings outside of class time, fostering negotiation, team building and teamwork skills.

Content (topics)

For solid dose products you will learn the technologies and controls of the key manufacturing processes granulation, blending and milling, compression and encapsulation. You will then learn about the downstream processes of packaging and labelling. Transitioning to other finished dose forms, you will then about formulation, preparation and manufacturing of oral liquids and topical products as well as the relevant packaging operations.

Assessment

Assessment task 1: Quiz

Intent:

Consolidate the early lessons from this subject and provide early feedback on your understanding of granulation technology and control in a pharmaceutical manufacturing setting.

Objective(s):

This task is aligned with the following subject learning objectives:

030

This task is aligned with the following course learning outcomes:

01.09, 02.01, 02.02, 02.04, 02.05, 02.06, 02.10 and 03.11

Type: Quiz/test
Groupwork: Individual
Weight: 5%
Length:

30 Minutes

Criteria:

Provided via Canvas

Assessment task 2: Equipment Technology Presentation

Intent:

Pharmaceutical manufacturers must ensure their equipment is fit-for-purpose, but the scope extends far deeper than product processing. This assessment has been designed for you to apply GMP and technical knowledge to a piece of equipment, practice your assessing skills and demonstrate your oral communication skills in a simulated pharmaceutical manufacturing scenario.

Objective(s):

This task is aligned with the following subject learning objectives:

031, 032 and 034

This task is aligned with the following course learning outcomes:

01.09, 02.01, 02.02, 02.04, 02.05, 02.06, 02.10 and 03.11

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

15 minutes plus 5 minutes for questions

Criteria:

Provided via Canvas

Assessment task 3: User Requirements Specification Assignment

Intent:

Advancing another step from assessment 2, this assessment relates closely to a real-life project scenario where a Production group have defined their needs and the Engineer (the student) will provide advice to take it further. The assessment allows you to demonstrate your ability to interpret requirements within the context of technical needs and GMP compliance.

Objective(s):

This task is aligned with the following subject learning objectives:

031, 034 and 035

This task is aligned with the following course learning outcomes:

01.09, 02.01, 02.02, 02.04, 02.05, 02.06, 02.10 and 03.11

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

1500 words (excluding references)

Criteria:

Provided via Canvas

Assessment task 4: Final Exam

Intent:

This exam gives you an opportunity to demonstrate your individual understanding of key concepts and procedures as would be used in an industrial setting

Objective(s):

This task is aligned with the following subject learning objectives:

030, 032 and 033

This task is aligned with the following course learning outcomes:

01.09, 02.01, 02.02, 02.04, 02.05, 02.06, 02.10 and 03.11

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

2 hours and 10 minutes

Criteria:

Provided via Canvas

Assessment task 5: Contribution

Intent:

Students will demonstrate leadership and collaboration skills with other students during facilitated workshops that reflect productive and supporting working relationships with colleagues expected in industry.

Objective(s):

This task is aligned with the following subject learning objectives:

030

This task is aligned with the following course learning outcomes:

01.09, 02.01, 02.02, 02.04, 02.05, 02.06, 02.08, 02.10 and 03.11

Type: Demonstration
Groupwork: Individual
Weight: 10%
Length:

n/a

Criteria:

Provided via Canvas

Minimum requirements

Students are required to attend a minimum of 85% of classes.

Required texts

Provided via the subject 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

Other relevant references as identified throughout course notes and lectures.