Good Manufacturing Practices for Manufacturing Operations
Unit code: HES6402
| Credit points | 12.5 Credit Points |
| Duration | 1 Semester or teaching period |
| Contact hours | 30 Hours |
| Campus | External Venue, Hawthorn |
| Prerequisites | Admission to one of the GMP suite of postgraduate programs or equivalent |
| Corequisites | Nil |
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).Aims and objectives
This unit of study is designed to carry the principles of GMP to industrial situations and to further the general exposure and skills of GMP. At the end of this unit of study students will 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.
* 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.
* Develop strategies for GMP upgrades, staff GMP training and compliance audit of therapeutic manufacturing facilities.
* Prepare validation plans.
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).
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.
Content
Cleaning & Sanitation:
Definition of the cGMP requirements for facility & equipment cleaning, sanitation programs & records.
Definition of the cGMP requirements for facility & equipment cleaning, sanitation programs & records.
Basic requirements for good housekeeping, staff personal hygiene & pest control.
Student should be able to audit current company cleaning & sanitation practices, & compare them with the cGMP requirements upon completion of this module. HACCP & Process Control Plans
How Hazard Analysis and Critical Control Points (HACCP) techniques can be used to map the controls over processes.
Principles are re-inforced using case studies.
Students should be able to effectively prepare a HACCP plan for a selected process upon. completion of this module. GMP Principles for Manufacturing & Packaging Operations
Manufacturing & packaging controls.
Requirements to minimise possibility of extraneous contamination, cross-contamination, mislabelling or incorrect packaging of products.
cGMP requirements for inward goods QC & sampling, dispensary controls, product contamination, line clearances, preprinted matter control, yield and reconciliation, release for sale & requirements for effective product recall. Microbiological Aspects of Pharmaceutical Manufacturing
Provide the non-microbiologists with an industry perspective into 'objectionable' micro-organisms in non-sterile pharmaceutical manufacturing, their likely source(s) & how they should be controlled under GMP.
The various (proposed) regulatory & pharmacopoeia standards, monitoring programs for raw materials, water systems & finished products.
Examines closely the microbial/GMP issues relating to the control over environment, water, personnel & equipment. Change Control Programs Change management is one of the most difficult but most important QA systems to implement is a company. The linkages and interactions affect most organisational groups - Production, Engineering, Quality Control, Regulatory Affairs, Development , IT and of course QA. Many regulatory citations and product recalls originate in poor change control practices. This modules covers the following topics:
What is change control?
Is change control different to document change control?
Levels of change and who is involved.
Regulatory requirements and guidance.
Some examples of change control - case studies and workshops. GMP Responsibilities for Managers and Supervisors
Role & responsibility of the line supervisor in a pharmaceutical manufacturing environment, concepts & practical information on how supervisors can influence & improve GMP compliance at the workplace.
The importance of systematic GMP & competency based training - how to set out a cGMP compliant structured training program.
Aspects of corrective & preventative action (CAPA), & some practical tips on how to manage effective CAPA systems.
