GMP Uplift

Overview

CBE GMP Uplift Programs will provide participants with a real-world perspective on Good Manufacturing Practice (GMP) and are designed to assist with the interpretation and application of GMP into practice, for those involved in human health products. CBE brings strong technical credentials, with experience across large and small Biologics, Pharmaceuticals and Regenerative Medicine companies, both in consulting and GMP related enterprise training.

This program is supported by MTPConnect’s $32 million Researcher Exchange and Development within Industry (REDI) initiative funded by the Medical Research Future Fund (MRFF). In delivering the REDI program, MTPConnect is partnering with research, training and industry organisations to deploy an integrated three-pillar plan driving skills and workforce development for the medical technology, biotechnology and pharmaceutical (MTP) sector nationally. Through a competitive process, MTPConnect has selected additional industry training providers to deliver new programs addressing key skills gaps in the sector workforce.

CBE will lead the Consortium, accompanied by ARCS Australia and Merck Life Sciences Australia; CBE Pure Solutions (VIC), Translational Research Institute TRI (QLD) and UTS Biologics Innovation Facility (BIF) (NSW) facilities are used for hands-on training in a GMP-like environment. The Programs will feature high calibre, relevant Guest Lecturer faculty to share real-world experiences.

CBE’s GMP Uplift Programs will provide participants with an industry relevant, practical and experiential GMP learning experience.

Relevant

Practical

Experiential


Essential GMP Program

The Essential GMP Program is designed for entry level employees (new starts up to 12 months) and is a 5-day equivalent course, designed for participant flexibility and to upskill in core GMP principles. It includes:

  • The first modules build the theoretical concepts of a Core GMP framework for all students, covering the GMP basics. 6 Core GMP modules covering fundamental concepts of GMP delivered virtual online or facilitated for larger groups.
  • Complementing this, participants will choose 2 Elective modules across Biologics, Pharmaceuticals, Regenerative Medicines and Quality Control delivered virtual and facilitated online or facilitated for larger groups.
  • The final two days are onsite, face to face and cover a GMP Workshop of case studies and the application of theory into practice. The application of theory into practice with a GMP Hands-on Workshop in an experiential GMP environment.
  • These are offered on scheduled days from Q3 2022 at either CBE Pure Solutions (VIC), TRI T3 Cleanrooms (QLD) or UTS Biologics Innovation Facility (BIF) (NSW).
  • Program costs are covered under REDI, places are limited.


Advanced GMP Program

The Advanced GMP Program, is for those working in a GMP role (12 months+) looking for an in depth understanding of the critical areas that underpin GMP compliance in practice. It includes:

  • 6 Advanced short courses, are complementary and for those wanting to upskill.
  • Each course will utilise a theory session, case study to demonstrate theory in practice and facilitated workshop with Q&A to explore the learnings from the case study.
  • Designed for busy professionals, the modules will have online components, with virtual facilitated sessions and will be scheduled from September 2022.
  • Program costs are covered under REDI, with a small co-payment.

All CBE programs will have live examples, case study work and assessments for certification, as well as guest lecturer content.

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GMP Uplift Consortia

COVID-19 has brought unprecedented focus on the Medical Technology, Biotechnology and Pharmaceutical (MTP) sector; highlighting the importance of research and development, new technologies and advancements to navigate human health challenges. This coupled, with the importance of sovereign capability and a robust supply chain to support the provision of essential MTP products. This has created unique opportunities to invigorate and invest for a stronger sector. However, these investments require the supportive infrastructure to ensure they can be realised. Skilled labour, in particular skilled in the manufacture of these MTP products, namely competency in GMP, is a vital piece of the puzzle.

The GMP Uplift training programs are developed by the Centre for Biopharmaceutical Excellence (CBE). CBE brings strong technical credentials, with experience across large and small Biologics, Pharmaceuticals and Regenerative Medicine companies, both in consulting and GMP related enterprise training. This coupled with extensive experience in GMP operations, compliance, auditing and QMS design, a wide industry network for guest lecturers and readily available case studies.

The GMP Uplift Consortia bring an experienced team, industry relevant content, state-of-the-art facilities and trainers to deliver programs to uplift GMP related skills. The team are committed to providing relevant, practical and experiential GMP education to develop the next generation of advanced manufacturing workforce to support Australia’s MTP sector and its growth plans.


ARCS Australia has a strong connection with large Pharma and MedTech companies operating in Australia, extensive experience in developing, organising, hosting and administering educational training content. ARCS has LMS and virtual Community engagement infrastructure and a talented team to manage the course administration and reporting elements to complement CBE’s technical experience. It also brings a wealth of experience in education and training within the MTP sector.


Merck Life Sciences Australia brings to the consortium significant hands-on experience in quality control methodology, particularly around biologics and microbiology technology. Merck regularly training their customer base in the application of their equipment and methods and will be able to lead the quality control hands on component of the course.


CBE Pure Solutions brings to the consortium an advanced specialist hands-on facility specifically designed for teaching in Melbourne VIC.


TRI T3 Cleanrooms bring to the consortium a state-of-the-art facility set up for biologics manufacture, in Brisbane QLD.


UTS Biologics Innovation Facility (BIF) brings to the consortium a state-of-the-art dedicated GMP-ready biologics facility set up for pilot scale manufacture, in Sydney NSW.


The facilities will be able to train people in applications such as gowning, cleanroom behaviour, operating a low bioburden filling line, environmental monitoring, microbiological techniques and aseptic practices.

Essential GMP Uplift

Training for Entry Level Employees

CBE consultants have worked in industry and consulted for decades within evolving GMP environments. This background has enabled us to have a clear vision of what is needed for entry level employees. We understand that, without context, the GMP rule can be confusing and seem somewhat arbitrary. This is the reason for Core GMPs, which are technology independent and provide fundamentals of why, what and how GMP rules are applied in different work functions and cover universal requirements/GMP principles. The Core GMP Modules will be online, have an assessment and are a pre-requisite for the Electives and Workshops. Prior to entry into the course participants will be required to pre-read resource information.

The four Electives are more specific GMPs tailored to each of three technologies plus laboratory Quality Control and provide GMP expectations within different technologies. Participants complete two Electives, allowing them to stream to modules that that relate to their workplace and have more specific examples, case studies and guest lecturers. The Electives will be virtual, on-line, facilitator lead and have an assessment.

On the completion of the six Core and two Elective GMP Modules, a one-day, face-to-face facilitator led, onsite GMP Workshop for feedback, problem sharing, group practice using case work, an opportunity to engage in Q&A and networking.

The last day enables the participants to apply in practice within a facility in a “hands on” learning environment. The experiential Hands-on GMP Workshop will familiarise participants with working in an industrial environment where they can practice GMP related activities. The simulated environments for the training are either TRI T3 Cleanrooms Brisbane, Queensland, UTS Biologics Innovation Facility (BIF) Sydney, NSW and CBE Pure Solutions, Melbourne, Victoria. The facilities can accommodate 8 - 12 participants for the on-site training. These may also be conducted at the client premises by agreement.

As an outcome by the end of the training program, attendees will have broad understanding of GMP principles, quote specific examples, understand basic GMP application in case studies and have practical hands-on experience of base concepts to operate entry level tasks in a GMP environment


Essential GMP Program

Course
CORE GMP 1
Introduction to GMPs, Regulations and Licensing
  • International GMPs and Regulatory Bodies
  • GMP license and how they are obtained
  • Tour of the cGMP and Annexes – finding rules
  • Relationship between GMP rules, employee behaviour and patient safety
CORE GMP 2
Quality Assurance
  • Role of the Quality unit
  • Pharmaceutical Quality Systems and key elements
  • How and where Quality Control is applied
  • Quality Assurance and the Supply Chain
  • Release of products to market
CORE GMP 3
GMP Documentation and Records
  • Importance of documentation – SOPs and Records​
  • Importance of the Master Batch Records and Specifications​
  • Rules for accurately completing GMP records ​
  • What does my signature mean
  • Introduction to Data Integrity
CORE GMP 4
Facilities, Cleanrooms, Materials and Equipment Controls
  • Principles of design and control for Facilities, Cleanrooms and Equipment
  • Design and operational considerations for Facilities, and Cleanrooms
  • Facility design, personnel and materials flow for different examples of manufacturing processes
  • Materials storage and management
  • Operation, maintenance and qualification
CORE GMP 5
Production and Contamination Control
  • What do cGMPs inform about production and contamination control
  • Process flows for Pharmaceuticals
  • Process flows for Sterile Products and Biologics
  • Where does contamination originate and how to prevent it
  • Importance of cleaning and sanitation
CORE GMP 6
Quality Control
  • Importance of Quality Control and Good Laboratory Practices (GLP’s)
  • Good documentation practice within Laboratories
  • Requirements for Analytical Laboratories
  • Requirements for Microbiology Laboratories
  • Working with Production
Elective 1
Biologics
  • Introduction to Biologics​
  • Biologics upstream and low bioburden processing​
  • Downstream purification processing steps ​
  • Aseptic Filling and Packaging​
  • Special contamination controls for Biologics​
Elective 2
Pharmaceuticals
  • Different types of Pharmaceutical dose forms
  • Unit Operations and their CPPs and CQAs
  • In-process controls and introduction to Control Charts
  • GMPs and controls for Oral Solid Dose (OSD)
  • GMPs and controls for Liquids and Creams (Topicals)
  • A typical batch record for a Pharmaceutical Product
Elective 3
Regenerative Medicine & Sterile
  • Introduction to Regenerative Medicines technology
  • What does Sterility Assurance mean to manufacturers and patients
  • Controls for sterile manufacture and potential contamination sources
  • Open and closed processing systems
  • Introduction to Regenerative Medicines technology
  • Regenerative Medicine production processes and quality control
  • The role of people in keeping patients safe
Elective 4
Advanced Quality Control
  • Role of the Quality Control Unit
  • Understanding pharmacopeias
  • Criticality of test records and data integrity
  • Test Method Validation
Case Workshop
  • GMP Case Study Workshop
  • The practical workshop will review concepts, discuss GMP interpretations and practice using an industry case study
  • The case study is used to illustrate the interpretation of the cGMPs in a simulated compliance situation and will have an assessment
Hands-On Workshop
  • GMP Hands-On Experiential Training in Facility
  • The objective of the day is to reinforce and practice the concepts raised during the program
  • It will cover activities such as gowning, working aseptically, environmental monitoring, laboratory testing

The program has been designed to be agile and for flexibility, it can be run via online, webinars and virtual facilitation or “in-house” at company locations face-to face or a combination by arrangement with the client. Working with REDI and the industry around needs, CBE will offer companies the option depending on trainee numbers, external environment and feedback received.

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Advanced GMP Uplift

Training for Senior Level Managers

Current GMP requirements are increasingly demanding and complex and getting it right first time has significant impacts on quality, regulatory compliance and business efficiency. Modern managers need to understand and work across different disciplines as part of a cohesive team. The six short courses are based on consultation with industry and our consulting experience where we often see knowledge gaps and sub-optimal application of these disciplines. In particular, the application of risk management has significant leverage over the other five topics and will be a common theme throughout the series.


Advanced GMP Program

The six courses are complementary and designed to super charge attendees for a more in depth understanding of critical areas that underpin GMP compliance in practice. Delivered in a virtual, online environment, ideal for busy professionals. Theoretical concepts will be translated to the real world environment and be supported with Guest lectures, self directed learning, Q&A facilitated sessions and case work. A minimum of 12 months working in a GMP role or the GMP Essentials Program are pre-requisites for the course.

Short Courses
Risk Management
Risk is a foundational concept, that can be applied to all other areas of Quality Management. This course will cover the expectations of Quality Risk Management (QRM) in the MTP sector. Participants will learn to identify and apply the processes of QRM, the qualitative and quantitative tools to assess risk and classify risk into classes and different applications for reactive vs proactive situations. As well as how to organise, facilitate and participate in effective risk assessments and constructing risk management reports.
Investigations and Root Cause AnalysisInvestigations and Root Cause Analysis (RCA) are vital tools for effective Corrective and Preventative Actions (CAPA) and Change management. This course covers problem investigations, RCA, CAPA and Change management, where participants will learn to identify key process steps for effective investigations, defining problems, investigation plans. Participants will learn the difference between symptoms and root causes, the application of QRM to determine actions, CAPA and continuous improvement via change management.
ValidationThe language and terminology of qualification and validation can be very confusing, complex and easily misunderstood. This course explains correct terminology, introduces participants to industry requirements for qualification and validation, as well as how to determine a “validated state”. It will give participants practical knowledge in the interpretation of validation requirements, to manage validation programmes and prepare documentation aligned with the GMPs. It covers qualification sequences, equipment assessments, cleaning limits, CCPs and CQAs and process controls.
Aseptic PracticesAseptic processing and the GMP rules are particularly complex and require expert interpretation and application. This course will provide an overview of many of the GMP rules for aseptic processing and enable participants to interpret Annex 1 requirements, as well as manage the risks associated with aseptic processes. Participants will gain an appreciation of the expectations for compliance when manufacturing sterile products, including media fills, clean room classifications, particulate monitoring, microbial monitoring and interpretation of environmental monitoring trends.
Audit ReadinessManaging a regulatory inspection is critical to successfully maintaining GMP compliance or obtaining a GMP License. It is evident that a well prepared site has a much higher chance of success than one that is not prepared.  Regulatory inspection can be stressful for all parties and everyone wants a balanced and fair outcome. This course explains what is expected from a regulatory inspection, how to apply the 4Ps approach and how to facilitate the right outcome from an inspection. Participants will learn how to be audit ready, prepare for an inspection, how interviews should be conducted and how to deal with any non-conformances.
Advanced QMSQuality Management is considered the most important GMP system and as such the functioning of the Quality Management System (QMS) is central during regulatory inspections. A QMS consists of 10 fundamental elements and this course explains the process flows for most these elements.  ICH Q10 now includes a continuous improvement requirement within the quality system and this is covered in the context of change management, quality metrics, auditing and management reviews.

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