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International Good Manufacturing Practices and Quality Assurance

Unit Code: HES6401




Duration

Contact Hours

Campus

Prerequisite

Corequisite

1 Semester or teaching period

30 Hours

External Venue, Hawthorn

Admission to the one of the GMP suite of postgraduate programs or equivalent.

Nil

Credit Points: 12.5 Credit Points

Related Course/s:

A core unit of study in the Graduate Certificate of Science (Good Manufacturing Practices), Graduate Diploma of Science (Good Manufacturing Practices) , Master of Science (Good Manufacturing Practices) and Master of Science (Good Manufacturing Practices and Quality Management) and an elective unit of study in the Master of Science (Biotechnology).

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Aims & Objectives:

This unit of study has been specifically designed for managers and supervisors who are responsible for implementing or maintaining GMP Compliance and Quality Assurance in the manufacture of human or veterinary therapeutic products. It will also be of relevance to anyone with a general interest in GMP and is aimed as an introduction, concentrating on international aspects and quality assurance.

At the end of this unit of study students will begin to be able to:

  • State the underlying principles of GMP & Quality, their significance in the industry, and develop practical strategies to apply those principles in the workplace.
  • Integrate GMP and ISO 9000 elements into a Quality System.
  • Identify areas of GMP non-compliance and propose and implement corrective actions.
  • Prepare a Quality Plan and audit their worksite for GMP compliance.
  • Define the current trends in International and Australian GMP compliance.
  • Prepare validation plans.
  • In addition, the participants are expected to gain an understanding of current requirements and future international trends within our industry.

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Teaching Methods:

Lectures/Tutorials, laboratory and/or experiential off-campus learning, case studies based on actual events that have occurred in the pharmaceutical and related industries will be used, web based unit presence (Blackboard).

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Assessment:

Indicative weightings: Test 10%, Assignments 50%, Exam 40%.

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Generic Skills Outcomes:

Students will be provided with feedback during the assessment for this unit of study on their progress in attaining the following generic skills:
 
  • Analysis skills,
  • Problem solving skills,
  • Communications skills,
  • Ability to tackle unfamiliar problems, and the

 

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Content:

QA Principle & International GMPs:

  • Historical developments of International codes of GMP (PIC/S, UK-MCA, US-FDA and TGA) & their evolution into International Compliance.
  • Veterinary codes of GMP – differences and similarities
  • Differences between regulations, codes & guides
  • Review fundamental requirements for GMPs & the obligations of Manufacturers and Managers .
  • Introduction to essentials for a GMP compliance program & introductory overview of the cGMP.

Quality Management, Quality Assurance and Quality Control:

  • Definition of the relationship between Quality Assurance, Good Manufacturing Practice, Quality Control and ISO9000.
  • G (QC) LP & its relationship with GMP.
  • Release for Sale and Marketing Authorisation.

Key Quality Assurance Systems:

  • Reviews some of the critical QA and GMP systems egg. requirements for:
  • Design & Change Control.
  • Deviation & Error Control.
  • Corrective & Preventative Action (CAPA).
  • Internal & External Audit Programs.

Documentation Systems and Practices - GMP Requirements & Control:

  • Fundamental cGMP requirements for documentation, content, format & control.
  • Structure & relationship between Manuals, Policies, SOPs, WIs, Records & other supporting documentation.
  • Discussion on a model hierarchical documentation system based on ISO 9000.
  • Training is emphasised as well as the importance of documents & records during GMP audits.

GMPs for Active Pharmaceutical Ingredients:

  • Review of the ICH cGMP for Actives (APIs).
  • GMP application to process stages.
  • State when GLP and GMP controls start.
  • Describe API validation programs.
  • Describe Process Control over APIs.

GMPs for Biotechnology:

  • Review of the cGMPs for Biotech. Products.
  • Describe GMP application to process stages.
  • State Master and Working Cell Bank requirements.
  • Explain GMP as applied to Purification Stages – Chromatography.

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Reading Materials:

Lecture notes (provided via Blackboard).

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Textbooks:

Printed notes will be supplied.

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