Dr. Florian Witte
Boehringer Ingelheim
Referent:innen
Dr. Björn Wiese
Janssen Cilag
Wolf-Dieter Wanner
Consultant
Michael Grosser
Lonza Biologics
Luigi Scaffidi
Boehringer Ingelheim Pharma
Dr. Bettina Rietz-Wolf
Regierungspräsidium Tübingen
Zielsetzung
GMP for Beginners in Sterile Manufacturing
The Online Training is designed for people working in sterile manufacturing to get basic knowledge of GMP.
- You get to know the most important pharmaceutical regulations for sterile manufacturing and their importance,
- You get a basic overview of general GMP requirements and specific requirements in sterile manufacturing and
- You become familiar with the most important basic processes in sterile pharmaceutical production.
Process Simulation / Media Fills
During this course you will learn in lectures and workshops
- The new requirements of the revised EU Annex 1
- How to plan a media fill in compliance with European and US GMP requirements,
- How to interpret the results of a media fill,
- How to investigate deviations and define follow-up measures and
- How QA should be involved
Hintergrund
GMP for Beginners in Sterile Manufacturing
Knowing and applying the GMP regulations is one of the key elements in the manufacture of medicinal products and medical devices. Particularly in the manufacture of sterile medicinal products, employees have to comply with extensive requirements. Against this background, employees have to know the GMP requirements and must know how to use them in practice.
The question is: how can employees implement in their daily work regulations which are usually formulated in a very general manner?
The question is: how can employees implement in their daily work regulations which are usually formulated in a very general manner?
The aim of the Online Training is to help answer this question and enable the concrete transfer of regulatory requirements into practice. Where are the main difficulties and how can they be solved pragmatically? The Online Training will present elements and situations which employees are regularly confronted with, like for example:
- Correct cleaning / disinfection
- Behaviour in clean rooms
- Correctly passing into the clean rooms
- Environmental Monitoring
- Performance of Media Fills
Aseptic Process Simulation (APS) / Media Fills
In the aseptic processing of medicinal products, the product quality usually cannot be ensured by means of lab controls of the final product. Process validation by means of media fills is the only way to furnish proof of product safety, which is why it justly is the focus of regulatory requirements and official inspections.
A number of revised and harmonised international regulations, especially the FDA Guidance for Industry „Sterile Drug Products Produced by Aseptic Processing“, the EU-GMP-Guide Annex 1, ISO 13408 and the PIC/S Guide „Recommendation on the Validation of Aseptic Processes“, define highly detailed requirements, the implementation of which is critically examined within the framework of official inspections.
In general, the required media fills should be able to simulate both routine operation and worst-case conditions.
In practice, the question of practicability often arises. How should the requirements be interpreted and how can they be implemented even for special production processes or dosage forms?
A number of revised and harmonised international regulations, especially the FDA Guidance for Industry „Sterile Drug Products Produced by Aseptic Processing“, the EU-GMP-Guide Annex 1, ISO 13408 and the PIC/S Guide „Recommendation on the Validation of Aseptic Processes“, define highly detailed requirements, the implementation of which is critically examined within the framework of official inspections.
In general, the required media fills should be able to simulate both routine operation and worst-case conditions.
In practice, the question of practicability often arises. How should the requirements be interpreted and how can they be implemented even for special production processes or dosage forms?
Zielgruppe
GMP for Beginners in Sterile Manufacturing
The Online Training is directed to staff from the healthcare Industry having no or little experience with the current GMP requirements for sterile manufacturing. This includes both employees who, after their vocational training, enter the pharmaceutical Industry and experienced colleagues who work for the first time in sterile manufacturing areas. Suppliers who have to understand the quality requirements of their customers should also attend this Course.
Process Simulation / Media Fills
This Education course is directed at staff from
- Production
- Quality Assurance
- Microbiological Quality Control
who are responsible for the planning and evaluation of Aseptic Process Simulation (Media fill) programmes.
It is also valuable for decision makers who have to deal with Process Simulation data within the framework of production release and Aseptic Process Validation.
It is also valuable for decision makers who have to deal with Process Simulation data within the framework of production release and Aseptic Process Validation.
Date & Technical Requirements
Date of the Live Online Trainings
GMP for Beginners in Sterile Manufacturing
Tuesday, 4 November 2025, 09.00 h – 17.30 h CET
Wednesday, 5 November 2025, 09.00 h – 17.30 h CET
GMP for Beginners in Sterile Manufacturing
Tuesday, 4 November 2025, 09.00 h – 17.30 h CET
Wednesday, 5 November 2025, 09.00 h – 17.30 h CET
Aseptic Process Simulation (APS) / Media Fills
Thursday, 6 November 2025, 09.00 h – 17.30 h (CET)
Friday, 7 November 2025, 09.00 h – 15.30 h (CET)
Technical Requirements
We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
GMP for Beginners in Sterile Manufacturing - 18/19 November 2025
Introduction – What is Specific for Sterile Manufacturing?
- What does sterile actually mean?
- Controlling raw material supply
- Sterilisation
- Sterile Manufacturing Facilities
- Process simulations
- Microbiological control
Regulations for Sterile Manufacturing
- Overview of regulation hierarchy
- Regulations on Aseptic Processing
- Applicable ISO standards
Microbiological Basics
- Characteristics of microorganisms
- Microbial growth
- Microbial identification techniques
- Detection methods and their limitations
Clean Rooms and Barrier Systems
- Differences in the technology
- Decontamination vs. Disinfection
- Validation aspects
- Environmental monitoring
- Risk considerations
Specific Training Requirements for Sterile Manufacturing
- Basics of microbiology
- Contamination sources and -transfer
- Clean rooms
- Hygienic behaviour
Cleaning and Disinfection
- Definitions
- Requirements - results – parameters
- Types of detergents and disinfectants
- Microbiological efficacy
- Compatibility of materials
- Types of application
- Surface wetting
Hygiene
- General definitions
- Purpose and function to pharmaceutical manufacturing with reference to personnel, surfaces, equipment
- Diversity of hazard – hazard analysis
- Clean room conception
- Gowning procedures
- Decontamination procedures
Case Study: Entering the Clean Area
- Requirements
- How to meet the criteria - practice
Entering a clean area is a very critical step to fulfil the GMP requirements. Employees must be trained and qualified and the gowning process must be validated. Attendees will learn different procedures and discuss the advantages and disadvantages.
Sterilisation Processes
- Controlling bioburden / pyroburden
- Autoclaving
- Filtration
- Dry heat
- Gamma irradiation
- Ethylene Oxide
Involvement of the Microbiological Lab
- Counting micro-organisms
- Identifying micro-organisms
- Process validation
- Validating the sterility test
- Raw material testing strategy
- Trouble Shooting
Environmental Monitoring
- Regulatory requirements
- Content and establishing of an environmental monitoring program
- Requirements concerning media and media suppliers
- Documentation and trending
Contamination Control Strategy (CCS)
- Something new?
- Requirements from EU GMP Guide Annex 1
- What does CCS include?
Media Fill
- Regulatory requirements
- Microbiological media types
- Process simulation contamination
- Sample incubation
- Laboratory work
- Formal report
Handling failures in Sterile Manufacturing
- Historic background
- Regulatory Requirements
- Example for a Non-conformity System
- Case studies
Case Studies „Establishing an Environmental Monitoring Program and Handling of Failures in Microbiology“
Some practical examples from a pharmaceutical company will be demonstrated and discussed with the attendees.
Some practical examples from a pharmaceutical company will be demonstrated and discussed with the attendees.
Inspections / Audits / Observations
- Preparing for a formal inspection
- Managing an FDA audit of sterile manufacturing
- Internal audit program
- Real world observations
- Your OOS and OOT process
Aseptic Process Simulation (APS) / Media Fills - 20/21 November 2025
Current Regulatory Requirements and Expectations of an Inspector
- EU-GMP Guide Annex 1
- Regulatory changes through the new EU GMP Guide Annex 1
- Contamination control
- Inspection practice, questions
- Design
- Interventions
- Visual inspection
- Target, Assessment
- Media Fill Observations
Requirements for Cleanroom Staff Qualification
- Staff qualification
- Staff disqualification
- Training
- Gowning qualification
- Qualification with APS (success control)
- Personnel Monitoring
Design of Media Fill incl. Exercise
- Overview PDA TR22
- Parameter, which have to be consider in MF design
- Different MF design alternatives
- Consideration of long filling times
- Consideration of holding times
- The role of the MF in aseptic personnel qualification
Requirements for Manual Processes
- Differences compared to conventional drugs
- Annex 1 9.39
- Challenges for the APS design
Risk Management During Media Fill (Bracketing / Definition of Simulations / Interventions)
- Approaches and parameters for bracketing concepts
- Classification and grouping of interventions
- Examples of simulations
- Influence of the barrier system
- Examples of risk management tools
QA-Oversight
- Regulatory requirements
- Different approaches to QA Oversight
- Oversight during Media Fill execution
- Link between Media Fill Interventions and Smoke Studies
Exercise: Risk-based Determination of Interventions
Microbiological Investigations and Environmental Monitoring as Part of the Media Fill
- EM and personnel monitoring during Media Fill
- Responsibility for execution
- Fertility testing of the growth medium
Incubation, Assessment and Evaluation
- Important conditions for visual inspection
- Personnel qualification
- Evaluation methods for the Media Fill
Managing Deviations - Root Cause Analysis
- Consequences of deviations in Media Fill
- Retrospective and prospective evaluation
- Relevant parameters in root cause analysis
Case Study: Managing Interventions
| ECA-Member*: | € 2990,- |
| Non ECA Member*: | € 3190,- |
| EU/GMP Inspectorates*: | € 1890,- |
| APIC Member Discount*: | € 3090,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Sterile Production Manager"
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Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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