Process Simulation/Media Fill
Im Auftrag der ECA Academy

11-12 October 2018

Berlin, Germany

Seminar Nr. 16118

Unser Seminarservice

Kosten

Non-ECA Members:	EUR 1690,--
ECA Members:	EUR 1490,--
EU GMP Inspectorates:	EUR 845,--
APIC Members (does not include ECA membership):	EUR 1590,--

Alle Preise zzgl. MwSt.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Colin Booth, The Binding Site, UK

Natasha Pain, Lonza Pharma & Biotech, Tokyo, Japan

Alexandra Stärk, Novartis Pharma Stein

Zielsetzung

During this course you will learn in lectures and workshops

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

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?

Zielgruppe

This Education course is directed at staff from Production, 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.

Programm

Media Fills – The Essential Background

Regulations affecting aseptic manufacture: EU GMP Guide Annex 1, FDA Aseptic Guide
PIC/S Guide ‘Recommendations on the Validation of Aseptic Processes’
What media fills consist of (in principle)

Media Fills – How to Design a Media Fill

What medium?
How many units?
How long?
Interventions?
Personnel?

Media Fills: Specific requirements for isolators and freeze dryers

Media fill design for isolators and freeze dryers
Special interventions into isolators and freeze dryers
Validation of standing times for isolators and freeze dryers
Isolator gloves

Media Fills – The Involvement of the Microbiology Lab

Why we use TSB: Limitations, BSE/TSE-free?
Problems with TSB: Contamination of the dehydrated medium (Bacillus), Issue with Mycoplasma, Irradiated dehydrate (effects of irradiation on growth)
Growth Support Checks: Pharmacopoeial organisms, Local isolates, Preparation of Cultures
Incubation temperatures
Inverting units during incubation
Aerobic vs. anaerobic media fills
Incubation and inspection

QA Oversight

Regulatory background

QA Oversight during Media Fill versus QA Oversight during routine production

How to perform QA Oversight?

Interpretation of QA Oversight results

Discussion of particular issues

Holding times
Container / Closure integrity after Media Fills
Holding Tanks

Media Fills and Personnel

Training and qualifying personnel for aseptic manufacture through media fill
Maintaining qualification
Regulatory requirements

Media Fills and Environmental Monitoring

Environmental monitoring activities during Media Fills
Handling deviations

Media as a Source of Mycoplasma Contamination in Process Simulation

Mycoplasma myths
Plant vs animal media
Process simulations
Media production
A new breed of media

Media Fills – Handling the outputs

Limits (practicalities and impracticalities)
Handling failures

Media Fill - Identification of contaminating microorganisms

What the regulators expect
Likely contaminants, unlikely contaminants!!
Isolating contaminating micro-organisms
Identification methods, including genetic
Mycoplasma contamination
What the identification tells you about the process

Regulatory Problems with Media Fills

What the regulators expect
Examples from Warning Letters
Examples from 483s

Workshop: Managing Interventions

Different kinds of interventions
Selection of interventions for media fills
Selection of interventions for personal qualification
Tracking of interventions between media fills
Assessment of interventions

This workshop involves participants in the issues to be resolved in the identification and management of interventions during media fills in order to answer the demand from the regulatory inspector – “what’s the name of the person making that intervention, please show me the evidence from media fills that she has been qualified to perform it”.
Workshop: Handling a Media Fill Failure

Types of failures
Evaluation of failures
Documentation requirements

The current regulations on media fills include strict acceptance criteria. But how do out-of-specification results and failures during media fills have to be handled? Which consequences does a media fill failure have? In this workshop, the participants learn how failures have to be evaluated and which consequences they have.

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Process Simulation/Media FillIm Auftrag der ECA Academy