Presented by
Management Forum
Maintaining a sterile production environment on an ongoing basis is critical in the production of sterile pharmaceuticals, and strict adherence to guidelines and relevant standards is required to minimize contamination risks and ensure product quality and safety. During this training, all changes in Annex 1 will be evaluated, and the minimum requirements that aseptic operations must meet will be discussed and presented to the participants through examples.
11-13 March 2025
+ 1-3 July 2025, 25-27 November 2025 »
from £1599
In August 2022, (14 years after its last publication), the long-awaited EU GMP guide Annex 1 was published and comes into force on 25 August 2023. Annex 1, which includes new expectations as well as detailing the existing requirements in the 2008 publication, has been aimed to be harmonized with other updated guides. The Annex 1 guide is a versatile document that outlines the various aspects of the aseptic process as well as personnel, facilities, equipment, production, and robust technologies. Maintaining a sterile production environment on an ongoing basis is critical in the production of sterile pharmaceuticals, and strict adherence to guidelines and relevant standards is required to minimize contamination risks and ensure product quality and safety. It is very important that the production equipment, the production environment, the production process, and the criteria to be met by personnel are clearly and comprehensibly evaluated in the main GMP documents.
During this training, all changes in Annex 1 will be evaluated, and the minimum requirements that aseptic operations must meet will be discussed and presented to the participants through examples.
This course will address all current aseptic process guidance and it will provide participants with the opportunity to refresh their knowledge. How to minimize the risks of quality risk management principles will be discussed and the basics of microbiology will be explained. Environmental monitoring, bioburden and sterility assurance will be evaluated through examples, and the terms of cleaning, disinfection, sanitation and decontamination will be explained.
In Annex 1, the principles of Contamination Control Strategy (CCS), which is one of the most important expectations, will be evaluated and guidance will be given on how to prepare a sample CCS. Examples of the expectations of the health authorities regarding sterilization and visual control will be presented, and the points to be considered in Heating, Ventilation and Air Conditioning (HVAC), Water, Steam, and Gas systems will be covered.
Clean room classification, Personal Air Lock (PAL), Material Air Lock (MAL) concepts, and critical aspects in Restricted Access Barrier Systems (RABS) and Isolator systems that are starting to replace clean rooms will be evaluated. In addition, robust production techniques such as Blow Fill Seal (BFS) and Form Fill Seal (FFS) will be emphasized. The inconveniences encountered due to the violation of the microbial rules that must be followed in sterile environments due to various reasons will be conveyed with sample applications.
Important aspects of critical aseptic process simulation operations, previously known as media fill, airflow visualization study, aseptic filling, and closure will be shared with the participants.
In the last part of the training, the expectations of the health authorities of quality assurance and aseptic operations will be included, and the expectations of regulatory authorities such as FDA, MHRA, TGA, WHO, PIC/S from aseptic operations and the new Annex 1 will be addressed, and the most common deviations will be evaluated with recommendations.
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.
In addition, under Annex 1 the qualification of aseptic production personnel, education and training requirements, and examples of personal skills they should have will be learned.
The expectations of the regulatory authorities and the questions that may be encountered in audits/inspections will also be discussed.
Personnel in the following roles and departments:
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 he is preparing his latest book on ‘GMP Audits’ which will be published by Taylor & Francis in 2023.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
11-13 March 2025
Live online
09:30-16:45 UK (London) (UTC+00)
10:30-17:45 Paris (UTC+01)
05:30-12:45 New York (UTC-04)
Timings may be different for each day
Course code 14580
Until 04 Feb
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for 7 days, no obligation
1-3 July 2025
Live online
09:30-16:45 UK (London) (UTC+01)
10:30-17:45 Paris (UTC+02)
04:30-11:45 New York (UTC-04)
Timings may be different for each day
Course code 14795
Until 27 May
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for 7 days, no obligation
25-27 November 2025
Live online
09:30-16:45 UK (London) (UTC+00)
10:30-17:45 Paris (UTC+01)
04:30-11:45 New York (UTC-05)
Timings may be different for each day
Course code 15097
Until 21 Oct
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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.
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3 days
Typical duration
Pricing from:
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
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: