96060 Good (Quality Control) Laboratory Practices
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Subject handbook information prior to 2025 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
This is a foundation subject in the Master of Good Manufacturing Practice (C04301). This subject aims to introduce good (quality control) laboratory practices for laboratory analysts and supervisors who are involved in regulated laboratories. The subject explores the fundamentals of, and the quality systems in place within, a regulated laboratory. The contribution of systematic competency-based training is examined.
Subject learning objectives (SLOs)
| 007. | Generate ideas and contributions within a group dynamic, demonstrating effective communication and collaboration |
|---|---|
| 024. | Demonstrate the ability to apply key principles and requirements for Good (QC) Laboratory Practices |
| 025. | Recommend and justify root causes and corrective and preventative actions for a given out of specification (OOS) scenario |
| 026. | Devise method validation strategies for analytical procedures to determine the critical influences on analytical results |
| 027. | Interpret statistical data and conduct statistical procedures commonly used in a laboratory setting |
| 028. | Determine the appropriate sampling plan and attributes for a given project |
| 107. | Apply a risk based approach to the calibration and qualification of laboratory equipment |
| 122. | Apply regulatory and industry standards for stability requirements to stability studies |
Contribution to the development of graduate attributes
Here students become familiar with the knowledge necessary to apply and conduct laboratory assessments in a compliant manner, to provide assurance to their customers of product quality at each stage of the pharmaceutical manufacturing process and across the span of its shelf life.
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.
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 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.
Content (topics)
In this subject you will learn about how GMP is applied to laboratory operations, starting with an introduction to regulated quality control testing including roles and responsibilities, raw data, records, traceability, documentation and handling out of specification events as well as root cause analysis. You will learn about the design and evaluation of stability studies and analytical method validation, particularly performance parameters and acceptance criteria, before looking more closely at the related areas of equipment qualification and calibration as well as basic statistics for Quality Control (QC). You will also learn about pharmaceutical sampling problems in industry associated with active or inactive "chemical" materials, printed or unprinted packaging materials, in-process materials and process water or finished product.
Assessment
Assessment task 1: On-going Graded Assessment
| Intent: | Throughout the semester students will have the opportunity to check their understanding of the course content via graded assessments through the Canvas platform. |
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| Objective(s): | This task is aligned with the following subject learning objectives: 007, 024, 025, 026, 027, 028 and 107 This task is aligned with the following course learning outcomes: .01, .02, .04, .05, .06, .08, .09 and .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: OOS Evaluation Presentation
| Intent: | Equally important to the implementation of G(QC)LP practices is the ability to communicate your understanding of the processes. This is more challenging when there is a potentially critical issue and this assessment will give you the opportunity to explore your ability to effectively communicate your technical knowledge based on a pharmaceutical industry example. |
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| Objective(s): | This task is aligned with the following subject learning objectives: 024 and 025 This task is aligned with the following course learning outcomes: .01, .02, .05, .06, .09, .10 and .11 |
| Type: | Presentation |
| Groupwork: | Individual |
| Weight: | 30% |
| Length: | 15 minutes |
| Criteria: | Provided via Canvas |
Assessment task 3: Stability Case Study
| Intent: | Stability studies are foundational to product safety and efficacy. This assessment represents an activity that is carried out regularly in QC stability teams and allows students to demonstrate their ability to apply regulatory and industry guidance to the management of stability programs.
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| Objective(s): | This task is aligned with the following subject learning objectives: 024 and 122 This task is aligned with the following course learning outcomes: .01, .02, .04, .05, .06, .09 and .11 |
| Type: | Case study |
| Groupwork: | Individual |
| Weight: | 25% |
| Length: | 2000 words |
| Criteria: | Provided via Canvas |
Assessment task 4: Reply to Warning Letter
| Intent: | The intent is for students to propose resolutions to problems encountered in the laboratory. Students are to write a report by addressing the non-compliances through the use of a warning letter. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 007, 024, 025, 026, 028 and 107 This task is aligned with the following course learning outcomes: .01, .02, .04, .05, .06, .09, .10 and .11 |
| Type: | Report |
| Groupwork: | Individual |
| Weight: | 30% |
| Length: | 1000 to 1500 words (excluding references) |
| 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 PIC/S Code of GMP, which you will use, must be kept for all subjects.
Other relevant references are:
- ISO 17025 General requirements for the competence of testing and calibration laboratories
- FDA ORA Laboratory Manual of Quality Policies
- FDA CFR GMP Regulations for Drug Products
- Pharmacopoeias (BP / USP / EP / JP)
- ICH Guidance QB4 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
- ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology
- ICH Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
- WHO Guidelines for Sampling of Pharmaceutical and Related Materials