University of Technology Sydney

96060 Good (Quality Control) Laboratory 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 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). 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
108. Demonstrate ability to select appropriate pharmacopoeial methods for different dosage 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)
  • 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)
  • 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

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.

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 in groups during collaborative and interactive experiences as well as an assessment. Students will need to coordinate group work, fostering negotiation, team building and teamwork skills. Students will need to demonstrate 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 GMPs apply 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 then learn about 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. Finally, you will learn about pharmaceutical stability programs and how to setup a GMP-compliant schedule.In this subject you will learn about how GMPs apply 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. You will then learn about 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. Finally, you will learn about pharmaceutical stability programs and how to setup a GMP-compliant schedule.

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.

Objective(s):

This task is aligned with the following subject learning objectives:

007

This task is aligned with the following course learning outcomes:

02.01, 02.02, 02.03, 02.04, 02.05, 02.06 and 02.08

Groupwork: Individual
Weight: 15%
Length:

30 Minutes

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.

Objective(s):

This task is aligned with the following subject learning objectives:

024 and 026

This task is aligned with the following course learning outcomes:

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

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

15 minutes

Criteria:

Provided via Canvas

Assessment task 3: Method Validation Report

Intent:

Test results from QC laboratories have a direct influence on GMP operations. Method validation ensures that test method is capable of producing (and reproducing) reliable results so it is critical and often inspected by regulators. This report allows you to relate method validation practices to the relevant regulations and demonstrate your technical understanding of method validation by focusing on critical elements for a nominated material.

Objective(s):

This task is aligned with the following subject learning objectives:

007 and 025

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: 25%
Length:

2000 words

Criteria:

Provided via Canvas

Assessment task 4: Final Exam

Intent:

This final exam will evaluate your overall understanding of basic statistics, pharmacopeial methods and sampling. You will be presented with issues encountered in the pharmaceutical industry. You are expected to apply the knowledge gained in statistics, pharmacopeial methods and sampling to resolve these issues and provide the most optimal recommendations.

Objective(s):

This task is aligned with the following subject learning objectives:

024, 027, 028, 107 and 108

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:

1 Hour

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 Policy

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