GMP for Beginners in Sterile Manufacturing + Aseptic Process Simulation (APS) / Media Fills - Live Online Training
including Case Studies and Exercises
18-21 November 2025
Course No. 21909
Speakers
Dr Bettina Rietz-Wolf
Regierungspräsidium Tübingen
Wolf-Dieter Wanner
Consultant
Luigi Scaffidi
Boehringer Ingelheim Pharma
Dr. Björn Wiese
Janssen Cilag
Michael Grosser
Lonza Biologics
Dr. Florian Witte
Boehringer Ingelheim
Note: All times mentioned are CET.
Objectives
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
Background
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 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?
Target Group
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.
Date & Technical Requirements
Date of the Live Online Trainings GMP for Beginners in Sterile Manufacturing Tuesday, 18 November 2025, 09.00 h – 17.30 h CET Wednesday, 19 November 2025, 09.00 h – 17.30 h CET
Aseptic Process Simulation (APS) / Media Fills Thursday, 20 November 2025, 09.00 h – 17.30 h (CET) Friday, 21 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.
Programme
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.
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
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