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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 2019 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 an understanding of the key principles and requirements for Good 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
029. Design and develop a stability program that meets Australian and international regulatory requirements

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

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

Students first learn about general laboratory operations and then how they are regulated before stepping into specific practices that strongly influence the GMP status of a QC lab. Students gain an understanding of method validation (and its pre-requisites - equipment qualification and calibration) before learning about sampling strategies to collect testing material and then the statistical analysis that is performed on the results from the validated methods.

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. Students will start learning about the regulatory requirements for, and industry guidance on good quality control laboratory practices. With a fundamental understanding of laboratory principles, this subject will elaborate on the details within nominated quality control areas. Specifically, students will learn about OOS, root cause analysis, CAPA, statistical analysis, analytical methods validation, sampling and stability studies.

Strategy 1: Student preparation for learning: Students read articles and news items, watch videos relevant to quality control, follow regulatory updates and notices as well as use of online resources, such as online lecture notes and case studies provided via UTS Online. 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 UTS Online.

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)

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: Review Quiz

Intent:

A review quiz is held to give you feedback on the progress in understanding key concepts and key elements to Good (Quality Control) Laboratory Practices. This serves as an early stage indicator about students’ progress and the provision of remedial actions if necessary.

Objective(s):

This task is aligned with the following subject learning objectives:

007

This task is aligned with the following course learning outcomes:

01.09, 02.01, 02.02, 02.05, 02.10 and 03.11

Type: Quiz/test
Groupwork: Individual
Weight: 10%
Length:

30 Minutes

Criteria:

Provided via UTSOnline

Assessment task 2: Mid-session Oral Exam

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 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 examples.

Objective(s):

This task is aligned with the following subject learning objectives:

007 and 024

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: Mid-session examination
Groupwork: Individual
Weight: 20%
Length:

15 minutes reading and preparation time followed by 15 minute oral exam

Criteria:

Provided via UTSOnline

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: 20%
Length:

2000 words

Criteria:

Provided via UTSOnline

Assessment task 4: Stability program assignment

Intent:

This assessment gives you the opportunity to work in a team environment as you would within an organisation to review technical information and GMP requirements and propose a stability program that will achieves the desired objectives within the product stability framework and be GMP- compliant. You would apply different strategies to satisfy the diverse climatic requirements for stability studies in different parts of the world.

Objective(s):

This task is aligned with the following subject learning objectives:

007, 027 and 028

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: Project
Groupwork: Group, individually assessed
Weight: 20%
Length:

2500 – 3000 words (excluding references)

Criteria:

Provided via UTSOnline

Assessment task 5: Final Exam

Intent:

Critical outputs from QC laboratories are results and data. Statistical analysis is essential to those outputs and can influence manufacturing decisions. Noting this criticality, this task will demonstrate your ability to review data and perform appropriate statistical analysis correctly

Objective(s):

This task is aligned with the following subject learning objectives:

026

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: 20%
Length:

1 Hour

Criteria:

Provided via UTSOnline

Assessment task 6: 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:

029

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:

Weekly, throughout the session

Criteria:

Provided via UTSOnline

Minimum requirements

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

Note: there is a must-pass assessment in this Subject. Please check assessment descriptions for details.

Required texts

Provided via the subject UTSOnline 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 Q1A(R2): Stability Testing of New Drug Substances and Products
  • ICH Q1B: Photostability Testing of New Drug Substances and Products
  • ICH Q1C: Stability Testing for New Dosage Forms
  • ICH Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products
  • ICH Q1E: Evaluation of Stability Data
  • 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