GMP for Beginners in Sterile Manufacturing

GMP for Beginners in Sterile Manufacturing

Berlin, Germany

Course No 15897


Costs

Non-ECA Members: EUR 1690,--
ECA Members: EUR 1490,--
EU GMP Inspectorates: EUR 845,--
APIC Members: EUR 1590,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Colin Booth, The Binding Site, UK

Michael Grosser, Novartis Pharma Stein

Wolf-Dieter Wanner

Dr Björn Wiese, Zimmer Biomet

Objectives

The course is designed for people working in sterile manufacturing who have no or little 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

Background

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 the 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 course is to help answering this question and presenting the concrete transfer of regulatory requirements into practice. Where are the main difficulties and how can they be solved pragmatically? The course 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

Target Group

The course 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.

Programme

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
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
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
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.

Workshop
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.

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