Dr Jean-Denis Mallet
Former Head of the Pharmaceutical Inspection Dpt. AFSSAPS
Referent:innen
Markus Multhauf
Consultant Pharmaceutical Engineering
Dr. Ingrid Walther
Pharma Consulting Walther
Dr Jan Rau
Dockweiler
Nikolaus Ferstl
Facility Engineering Services
Dr Markus Keller
Fraunhofer Institute for Manufacturing Engineering and Automation (IPA)
Zielsetzung
This course explains how the requirements laid down in the GMP and FDA regulations can be put into technological and Engineering practice. The whole lifecycle from the design, the qualification and the maintenance of equipment is covered. The Annex 15 of the EU GMP Guide plays an important role here as well.
Hintergrund
Technical compliance is a wide field, especially when taking into account the ICH framework which covers the whole lifecycle of pharmaceutical manufacturing.
It does not only mean to comply with regulatory guidelines but also with submissions and the technological state of the art, meaning ISO and other standards as well as accepted good practices in the pharmaceutical industry.
In this GMP course we want to focus on the main topics with regard to compliance in the technical Environment:
Technical QA aspects
There are a number of quality assurance systems which are crucial for the technical units. Most important are changes and deviations (as they also can occur in technical environment) which have or might have a direct impact on the pharmaceutical material produced. And even more important is the validation system, where the qualification of equipment, utilities and facilities has to be part of.
There are a number of quality assurance systems which are crucial for the technical units. Most important are changes and deviations (as they also can occur in technical environment) which have or might have a direct impact on the pharmaceutical material produced. And even more important is the validation system, where the qualification of equipment, utilities and facilities has to be part of.
GMP Facility & Re-Construction
Designing an appropriate layout belongs to this part as well as understanding what the GMP requirements for the cleanrooms and for the HVAC systems are, depending on the type of manufacture. Re-Construction during on-going manufacture is supreme discipline in this field.
Designing an appropriate layout belongs to this part as well as understanding what the GMP requirements for the cleanrooms and for the HVAC systems are, depending on the type of manufacture. Re-Construction during on-going manufacture is supreme discipline in this field.
GMP-compliant design of equipment
A GMP-compliant design of equipment is the basis for fulfilling the technical requirements. In this respect, engineering assumes a prominent role in ensuring the safety of medicinal products. In this context, the need for material certificates is often subject to discussion.
A GMP-compliant design of equipment is the basis for fulfilling the technical requirements. In this respect, engineering assumes a prominent role in ensuring the safety of medicinal products. In this context, the need for material certificates is often subject to discussion.
Validation / Qualification
Not only GMP regulations but also inspectors consider qualified equipment and validated processes as the prerequisites for producing pharmaceutical quality. The identification of the Equipment that has to be qualified by means of a risk analysis is a crucial point. This field has now re-gained considerable attention as the regulations are changing: After FDA’s new guide on Validation (and process verification) also Annex 15 of the EU GMP Guide has been revised.
Not only GMP regulations but also inspectors consider qualified equipment and validated processes as the prerequisites for producing pharmaceutical quality. The identification of the Equipment that has to be qualified by means of a risk analysis is a crucial point. This field has now re-gained considerable attention as the regulations are changing: After FDA’s new guide on Validation (and process verification) also Annex 15 of the EU GMP Guide has been revised.
Routine Operation
Preventive maintenance in pharmaceutical production is an essential element of the Pharmaceutical Quality System. Systems for calibration & handling of repairs are of equal importance for maintaining the qualified state. That’s why maintenance and calibration are parts of an efficient requalification system, besides the change control and deviations systems of course.
Preventive maintenance in pharmaceutical production is an essential element of the Pharmaceutical Quality System. Systems for calibration & handling of repairs are of equal importance for maintaining the qualified state. That’s why maintenance and calibration are parts of an efficient requalification system, besides the change control and deviations systems of course.
Zielgruppe
This course is directed at staff in pharmaceutical engineering departments, at technicians, engineers, planners as well as plant constructors and equipment suppliers who are involved in Tasks related to engineering work in a cGMP environment.
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Programm
QA systems with technical relevance
Part 1:
Change Control, Technical Changes and Marketing Authorisations
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
- Examples
Risk Analysis
- Managing risks in the technical Environment
- Project risks
- Equipment risks
- Product risks
- Risk management Tools
- Examples
Integrated Commissioning & Qualification
- Old V-model and new approaches
- Project Steps & GMP regulations
- Quality Overview & Control for Project Work
- GEP, SME, CQA & CPP: Keys for Commissioning & Qualification - Process
- What to include in an URS - & what not
- PID, Layout, Component-list, FDS, SDS, HDS, Material Certificates
- Re-construction vs. Green Field Projects
GMP Zone Concepts (sterile/non-sterile/highly potent)
- 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 personnel & material flows
- Product vs Personnel 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 in a cleanroom
- Requirements on construction of floors, ceilings and walls
- Classification, Qualification, Requalification of Cleanrooms
What does GMP-compliant Design mean?
- GMP-Design & -Risk: It depends on the product…
- Special cases / Parts / Procedures: Heat Exchanger, Sampling Valves, Power Supply Safety, Clean-Room-Screw, Thread lubrication
- Cleanability, Turbulent Flow & Surfaces / Biofilm
- Drawings: PID-Symbols & 3D-rule
- Pest Control during construction & maintenance
- Documentation GEP vs. “ALCOA-plus”
- IT-life-cycle for GMP-Equipment
Basic Aspects of Hygienic Design and Material Selection
- Risk-based approach for the selection of suitable materials
- Equipment-specific definition of the hygiene-critical area
- Open & closed Equipment
- Construction aspects
- Cleanability
- Drainability
- Pipe Connections
- Screw Joints
- Inner corners and angles
Process Contact Surfaces: Specifications and Surface Treatments
- Definitions of surface qualities
- Surface quality requirements
- Surface treatment Methods
- Mechanical Treatment
- Chemical Methods
- Electrochemical treatment
Pipework and Fittings, Connections, Welding & Seam Control
- Piping & Tubing Standards
- Cleanability & Dead Legs
- Detachable Connections
- Welding Technology & Welding Quality Criteria
Requirements for the Process Environment: the Clean Room
- Clean Room standards and classes
- Selection and procurement - factors influencing the selection of components
- Wall and ceiling Systems
- Acceptance tests for wall and ceiling
- Requirements for clean room doors
- Floor Systems
- Acceptance tests for Floors
- Critical clean room interfaces
- Application of components for different cleanliness classes
Upgrading, Re-Construction and Renovation of Facilities
- Required as built documentation to start
- What to consider in re-construction projects?
- Upgrade of an HVAC System
- How to protect the ongoing manufacturing operations
- Protection of products
- Protection of equipment, rooms and HVAC
- Flow concepts and control of external personnel
- Access control, pest control, cleaning
- Documentation of protective measures
- Examples from recent projects
GMP Utility Systems (Water / Steam / Gases)
- eneration: From Source Review to Purified Water, WFI, Pure Steam
- Components: working principles (Softener, EDI, RO, UF...)
- Storage and Distribution concepts
- Sanitisation principles
- Automation, Instrumentation, Trending
- Specification & Design for Compressed Air
- Safety for Nitrogen-Systems
- API contaminated waste water
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
Recording from 9-11 April 2024
Duration of the recording: approx. 15 h
Duration of the recording: approx. 15 h
| ECA-Member*: | € 2090,- |
| Regular Fee*: | € 2290,- |
| EU/GMP Inspectorates*: | € 1145,- |
| APIC Member Discount*: | € 2190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager"
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E-Mail: info@concept-heidelberg.de
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