GMPs for Equipment, Utilities and Facilities
- 19.03.2019 - 21.03.2019
- Wien, Österreich
- CONCEPT HEIDELBERG GmbH
QA systems with technical relevance
Part 1: Change Control, Technical Changes and Marketing Authorisations
- Regulatory Requirements
- Identification of „Changes“ - What has to be handled under Change Control?
- CC-Workflow and pitfalls
- Change Management in Routine Operations vs. Project work
- Marketing Authorization - Regulatory Affairs for Engineers
Part 2: Deviations, CAPA & Malfunctions
- Deviations in the technical environment
- Documentation in logbook and higher-level systems
- Evaluation of technical deviations
- When does a deviation require CAPAs?
- Handling of alarms
- Correlation between changes, deviations, repairs and maintenance
- Managing risks in the technical environment
- Project risks
- Equipment risks
- Product risks
- Risk management tools
Qualification, Re-Qualification & Commissioning
- What to write in a URS & what not
- Using risk analysis from kick-off to routine operation
- Handling impact and non-impact systems
- From URS to PQ: step by step
- How to ensure traceability?
- System Verification / Validation
- Re-Qualification: How to..? And how often?
Materials and Surfaces
- Which materials can be used and for what purpose?
- Stainless steel, plastics, polymers,…
- How smooth have surfaces to be? Roughness and structures of cleanable surfaces
- What are the requirements on welding?
- Effects of corrosion, failures, and damage
GMP-compliant Equipment Design
- Open and closed systems
- Overview on important construction details for sterile and non-sterile applications
- Design of gaskets and problems with gaskets
- Allowed lubricants
- Examples of GMP-compliant equipment
GMP Zone Concepts (sterile/non-sterile/highlypotent)
- Basic GMP requirements for materials & pharmaceuticals handling
- Physical requirements (areas) vs Dynamic requirements (HVAC)
- Finding the correct requirements depending on the manufacturing operation
- Defining an appropriate layout and air lock concept
- Defining personal & material flows
- Product vs Personal Protection
- Product Protection concepts, types of air flows
- Avoiding Cross Contamination: the EMA idea
- The future of barrier systems (isolator and RABS)
GMP Class Requirements (HVAC and Barrier Systems)
- Some HVAC system concepts (e.g. fresh air / recirculated air)
- Understanding the main parameters (volumes, pressure, cleanliness, etc.)
- GMP Classification and ISO standards, and their interaction
- The basics of air filtration and flushing air circulation
- Particle testing depending on the cleanroom zone
- Microbiological monitoring on a cleanroom
- Requirements on construction of floors, ceilings and walls
- Classification, Qualification, Requalification of Cleanrooms
Upgrading, Re-construction and Renovation of Facilities
- Required as built documentation to start
- What to consider in re-construction projects?
- How to protect the ongoing manufacturing operations: Protection of products, Protection of equipment, rooms and HVAC, Flow concepts and control of external personal, Access control, pest control, cleaning, Documentation of protective measures, Examples from recent projects
Qualification and Management of Technical Suppliers
- Contract management: Commercial- vs. Engineering- vs. GMP-issues
- Selection and auditing of suppliers with a risk based approach
- How much GMP must a supplier have?
- Review of suppliers and their performance
- How to audit a technical supplier?
- Examples of managing suppliers for equipment, technical services, ..
Pharmaceutical Water Systems
- Regulation basics
- Generation: Purified Water, WFI, Pure Steam
- Components: working principles and hazards (Softener, EDI, RO,...)
- Storage and Distribution concepts
- Sanitisation principles, avoidance of biofilms
- Automation, Instrumentation, Trending
- How to handle OOS in a water system
Maintenance & Calibration
- Life-cycle model of pharmaceutical equipment
- How to set up and maintain a maintenance/calibration system
- Definition and control: frequencies, activities, tolerances, acceptance criteria, etc.
- Timing of activities
- Documentation & labeling
- Data integrity
Impact of the new GMP Thinking on Engineering
- Impact of the new Annex 15
- State of validation / qualification in the US
- Impact of ASTM E 2500 on European projects
- Changes coming from ICH Q 8-10
- How to comply with EU and US requirements in technical projects
- Practical examples
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