GMP for Beginners in sterile manufacturing + Process Simulation

GMP for Beginners in sterile manufacturing + Process Simulation

Berlin, Germany

Course No 17347



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Michael Grosser, Novartis Pharma Stein
Wolf-Dieter Wanner
Dr Björn Wiese, Zimmer Biomet
Dr Florian Witte, Boehringer Ingelheim Pharma
Natasha Pain, Lonza Pharma & Biotech
Alexandra Stärk, Novartis Pharma Stein
Dr Florian Witte, Boehringer Ingelheim Pharma


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
 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
Workshop: 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
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
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?
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”.

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
  •  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
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.

Media Fill - Identification of contaminating micro-organisms
  •  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 483’s

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