- Date:
-
- Seminar
Umgang mit Abweichungen in der Sterilproduktion (S 9) + Mikrobiologisches Umgebungsmonitoring (S 6)
- Event location:
- Karlsruhe
- Organizer:
- CONCEPT HEIDELBERG GmbH
Program S 9
Deviation Management from the Authority's Perspective / Handling Deviations / Inspection Procedures
- European Requirements (AMG, AMWHV, EU GMP Guideline)
- ICH Q10
- What does the inspector expect?
Handling Deviations: General
- Definition and classification of deviations
- Recording, assessment, and documentation of deviations
- Root cause analysis
- Corrective actions
- Preventive actions
- Evaluation of the deviation system / Self-inspections / Product Quality Review
Deviations in Sterile Manufacturing: How can errors be detected?
- Contamination possibilities
- Product flow
- Breaking of barriers
- Entry into the clean zone
- Handling errors
- Errors in microorganism removal
- Error detection
- Limit violations in environmental monitoring
- Errors in in-process controls and release tests
- Recalls
- Media fills
- Audits / Inspections
Practical Case Studies
In various case studies, the presenter will introduce deviations from operational practice. Focus areas include deviations in
In various case studies, the presenter will introduce deviations from operational practice. Focus areas include deviations in
- Aseptic process simulation (APS)
- Microbiological environmental monitoring
- Sterility testing
- Bioburden testing
- Isolator gloves
- Particle monitoring
The presenters will explain the procedures for each example and show the measures taken:
- Case description
- Proof of deviation
- Preliminary risk analysis
- Scope of investigations
- Investigation results
- Risk analysis
- Discussion of corrective measures
- Discussion of preventive measures
Program S 6
Current Regulatory Requirements and Inspector Expectations
- EU-GMP Annex 1
- PIC/S Guidance
- FDA Aseptic Guide
- USP Chapter
- Industry Guidelines: PDA Technical Report
Observations During Regulatory Inspections
- Required documents
- Common mistakes
- Employee qualifications
- Trending of results
Development and Establishment of a Microbiological Environmental Monitoring Program
- Regulatory requirements
- What does a microbiological environmental monitoring program include?
- Materials, methods, equipment
- Sampling
- Frequencies and timing of monitoring
- Special considerations for monitoring RABS systems and isolators - Requirements for nutrient media and their suppliers
- Microbiological incoming goods inspection of nutrient media
- Preparation of a testing plan (procedure, involved parties, documentation, risk analysis)
Case Study / Workshop “Practical Aspects of Microbiological Environmental Monitoring”
Air Monitoring Program
- Testing methods
- Comparative studies
- Rapid methods
- Incubation conditions
Surface / Personnel Monitoring Program
- Testing methods
- Swab evaluation study
- Procedure for deviations
- Methods of microorganism identification
Microbiological Aspects of Monitoring
- Environmental controls
- Limits of environmental monitoring
- Nutrient media & house isolates
- Validation of nutrient media shelf life
- Inactivation of disinfectants
Microbiological Monitoring in the Production of Non-sterile Preparations including USP
- Necessity
- Room classification
- Levels
- Sampling points
- Frequencies
Trending of Environmental Monitoring
- Definition of “trend” in general
- Trend report for non-sterile production
- Trend report for sterile production
Microbiological Environmental Monitoring – What Else Belongs?
- Monitoring of product-contact surfaces – cleaning monitoring or environmental monitoring
- Monitoring of media
- From sampling to laboratory – qualification of samplers and transport time validation
- Special considerations in sterile production
Case Study / Workshop: "Root Cause Analysis of OOLs & OOTs"
- System for handling microbiological deviations
- Deviations in sterile production
- Deviations in the manufacturing of non-sterile dosage forms
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Germany
Phone: +49 6221 844415
Fax: +49 6221 844464
email: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
