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GMP (Good Manufacturing Practice) Principles in Vaccine Manufacturing Training Course

Vaccinology continues to advance and mature impressively, both in developing new and improved vaccines and in administering vaccines to prevent disease. On this course, explore GMP principles in vaccine manufacturing.

14-15 November 2024
+ 16-17 April 2025, 10-11 September 2025 »

from £1099

Need help?  Enrol or reserve

Course overview

In this two-day training, the history of vaccines and adverse events will be discussed, information will be presented about various vaccine types and production platforms, raw material, production, quality control, quality assurance, storage, and distribution processes in a GMP-compliant vaccine facility will be explained to the participants with examples and real-time scenarios.

With the advent of vaccine development, life expectancy has increased and the quality of life has improved visibly. Vaccinology continues to advance and mature impressively, both in developing new and improved vaccines and in administering vaccines to prevent disease. Some vaccines used today were developed in the 1940s and 1950s and have remained virtually unchanged. This situation is not surprising for experts who can read the pharmaceutical industry and the ecosystem dynamics that develop around it well. Just like small molecule chemical drugs, to maximise the life cycle of a vaccine, the most important prerequisite is that the raw materials, components, and consumables are in the same composition and consistency from the beginning.

The SARS-CoV-2 pandemic highlighted the importance of vaccines to control the consequences of COVID-19. Most of these GMP facilities are in the EU, USA, China, and European countries. To facilitate the access of these types of products to the rest of the world, the expansion of production capacities and installation of new GMP production plants is essential.

To optimise vaccine production processes and develop efficient and effective processes, it is necessary to continuously supply quality raw materials from reliable suppliers that have been audited and approved by internationally recognised, certified, competent, and experienced GMP auditors.

Compliance with cGMP requires setting up a quality system (QS), which will vary in complexity according to the size of the company. However, there are some basic principles to be followed in terms of design, manufacture, validation, quality control, packaging, labelling, and storage. As it is known, the use of living organisms in the vaccine manufacturing process brings safety requirements to the fore. This situation points to a more complex structure outside of traditional drug production.

One of the most obvious risks in vaccine production is undoubtedly cross-contamination. In such a risky environment, the importance of ensuring the cleanliness and safety of the area, equipment, and personnel and cleaning and disinfection increases. GMP compliance and safety requirements brought about by the use of negative and positive pressure rooms are some of the challenges of vaccine production. Although innovative approaches such as mRNA technology seem to minimise some risks, there is still a lot to be done.

This course will provide an excellent opportunity to become fully briefed on the GMP principles in vaccine manufacture and enable participants to discuss the techniques with an expert in this field.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

Benefits of attending

On this course, participants will:

  • Gain information about vaccine manufacturing technologies
  • Understand the advantages and disadvantages of different production platforms 
  • Learn the differences between vaccine and traditional drug production
  • See how to adapt risk management principles and contamination control strategy to a facility
  • Explore detailed information about biosafety cabinets and their uses
  • Look at insights into the principles of raw material controls, production, quality control, release, storage and distribution in a GMP-compliant vaccine production facility
  • Focus on examples of how difficulties in vaccine production can be overcome
  • Appreciate the chance to take a closer look at viral, subunit and mRNA GMP applications
  • Examine concepts such as viral safety, stability and TSE in vaccines through examples
  • Assess the information about upstream, downstream and cell banks
  • Form an opinion on the layout plan of a vaccination facility

Who should attend

Personnel from these job departments will benefit from the course:

  • Quality Control
  • Quality Assurance
  • Manufacturing (Upstream & Downstream)
  • Engineering
  • GMP Compliance
  • Audit   
  • Suppliers to Vaccine Manufacturers

Enrol or reserve

This course will cover:

History of vaccines

  • Why and how were vaccines developed?
  • What are the technological developments from the first vaccine to today?
  • Making, purifying, formulating

Vaccine types and manufacturing platforms

  • Live attenuated vaccine types
  • Non-live vaccine types
  • New types of vaccines

Viral vector vaccines & GMP

  • Media & inoculum
  • Cell growth
  • Clarification
  • UF/DF
  • Purification
  • UF/DF
  • Formulation, sterile filtration

Subunit vaccines & GMP

  • Media & inoculum
  • Cell growth
  • NA removal
  • Clarification
  • Chromatography
  • UF/DF
  • Virus removal
  • Formulation, sterile filtration

mRNA vaccines & GMP

  • Plasmid
  • Chromatography
  • In-vitro transcription
  • Chromatography
  • Capping
  • Chromatography
  • UF/DF
  • Encapsulation
  • Formulation, sterile filing

Vaccine components

  • Adjuvants
  • Stabilisers
  • Buffers
  • Solvents
  • Preservatives
  • Animal derived ingredients

Group exercise – health authority inspection citations about vaccine manufacturers

Traditional platforms for protein-based vaccines

  • Bacteria
  • Yeast
  • Insect
  • Mammalian
  • New approaches

Upstream processing essentials

  • Example vaccine antigens
  • Critical quality attributes
  • Critical process parameters
  • Critical material attributes
  • How to maintain stable cell lines?

Downstream processing essentials

  • Purification principles
  • Which chromatography method to choose? How many?
  • Viral clearance essentials
  • Filtration methods best practices 

Stability of vaccines

  • Stability concerns
  • Buffers and stabilisers in vaccine stability

Lyophilisation of vaccines

  • Lyophilisation and validation
  • New Annex 1 expectations for Lyophilises

Group exercise – how to select a final container for a vaccine?

Quality control of vaccines

  • Which tests are performed?
  • Technology transfer issues
  • Method validation
  • Analytic requirements on vaccine manufacturing

Manufacturing constraints of vaccines

  • Purity vs cost
  • Central vs distributed manufacturing
  • Vaccine manufacturing failures
  • Timing of investments
  • GMP deficiencies of vaccine manufacturing

How to design a vaccine facility

  • Cleanroom design rules
  • Containment approaches
  • Risk-based principles of design purposes
  • Segregation
  • Hygiene
  • Airlocks & pressure differentials
  • Personal gowning
  • Contamination control strategy

Enrol or reserve

Mustafa Edik

Mustafa Edik is an Independent GMP Consultant and Auditor.  

After graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry. 

He has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies.

While he was the Vice President of Quality and Technical Operations at a Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines.

He finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University - Ireland. He is the author of chapter 6 of the book published by PDA named “Good Distribution Practices” and his new book on ‘GMP Audits in Pharmaceutical and Biotechnology Industires’ will be published by Taylor & Francis in June 28, 2024.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

14-15 November 2024

Live online

09:30-16:30 UK (London) (UTC+00)
10:30-17:30 Paris (UTC+01)
04:30-11:30 New York (UTC-05)
Course code 15225

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 10 Oct

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Not ready to book yet?

for 7 days, no obligation

16-17 April 2025

Live online

09:30-16:30 UK (London) (UTC+01)
10:30-17:30 Paris (UTC+02)
04:30-11:30 New York (UTC-04)
Course code 15226

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 12 Mar

View basket 

Not ready to book yet?

for 7 days, no obligation

10-11 September 2025

Live online

09:30-16:30 UK (London) (UTC+01)
10:30-17:30 Paris (UTC+02)
04:30-11:30 New York (UTC-04)
Course code 15227

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 06 Aug

View basket 

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Training expert

+44 (0)20 7749 4749