Dr Bettina Rietz-Wolf, Inspector
Luigi Scaffi di, Boehringer Ingelheim Pharma
Dr Florian Witte,Boehringer Ingelheim Pharma
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
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?
This Education course is directed at staff from
- Quality Assurance
- Microbiological Quality Control
who are responsible for the planning and evaluation of 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.
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Current Regulatory Requirements and Expectations of an Inspector
- EU-GMP Guide Annex 1
- Regulatory changes through the new EU GMP Guide
- Annex 1 Draft
- Contamination control
- Inspection practice, questions
- Visual inspection
- Target, Assessment
- Media Fill Observations
Requirements for Cleanroom Staff Qualification
- Staff qualification
- Staff disqualification
- 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
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
- Regulatory requirements
- Different approaches to QA Oversight
- Oversight during Media Fill execution
- Link between Media Fill Interventions and Smoke Studies
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
Recording from 14/15 October 2021
Duration of the recording: approx. 6 h 35 min