Aseptic Process Simulation (APS) / Media Fills - Online Training Recording
Course No. 21434
Speakers
Dr. Florian Witte
Boehringer Ingelheim
Dr. Bettina Rietz-Wolf
Regierungspräsidium Tübingen
Luigi Scaffidi
Boehringer Ingelheim Pharma
Objectives
During this online training 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
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
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.
Technical Details
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.
Please be aware: The recording does not include the Q & A sessions.
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.
Programme
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
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
Recording from 09/10 November 2023 Duration of the recording: approx. 7 h 33 min
This course is part of the GMP Certification Programme "ECA Certified Sterile Production Manager" Learn more
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