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.
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
Course Content
Day 1
Course Provider
Mustafa Edik,
Independent GMP Consultant and AuditorAfter 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 he is preparing his latest book on ‘GMP Audits’ which will be published by Taylor & Francis in 2023.
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
