- Datum:
-
- Webinar
GMP for Beginners in Sterile Manufacturing + Aseptic Process Simulation (APS) / Media Fills - Live Online Training
- Veranstaltungsort:
- online
- Veranstalter:
- CONCEPT HEIDELBERG GmbH
GMP for Beginnners in Sterile Manufacturing - 7/8 November 2023
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
Case Study: 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.
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
Aseptic Process Simulation (APS) / Media Fills - 9/10 November 2023
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
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Deutschland
Telefon: +49 6221 844415
Telefax: +49 6221 844464
eMail: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
