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 Markus Keller
Fraunhofer Institute for Manufacturing Engineering and Automation (IPA)
Dr Jan Rau
Dockweiler
Nikolaus Ferstl
Facility Engineering Services
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.
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.
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.
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.
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.
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.
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 deviation 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.
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.
Date & Venue
Date
Tuesday, 3 June 2025, 09.00 to approx. 17.00 h
(Registration and coffee 08.30 – 09.00 h)
Wednesday, 4 June 2025, 08.30 to approx. 17.15 h
Thursday, 5 June 2025, 08.30 to approx. 14.45 h
(Registration and coffee 08.30 – 09.00 h)
Wednesday, 4 June 2025, 08.30 to approx. 17.15 h
Thursday, 5 June 2025, 08.30 to approx. 14.45 h
Venue
HYPERION Hotel München
Truderinger Straße 13
81677 München, Germany
Truderinger Straße 13
81677 München, Germany
Programm
Gesamtes Programm als PDF herunterladen
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 Authorisation – Regulatory Affairs for Engineers
Part 2:
Deviations, CAPA & Malfunctions
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
Requirements and Components for Hygienic Tubing
Systems, Welding & Weld Examination
- 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)
- Generation: 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
| ECA-Member*: | € 2290,- |
| Non ECA Member*: | € 2490,- |
| EU/GMP Inspectorates*: | € 1245,- |
| APIC Member Discount*: | € 2390,- |
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
Aufzeichnung 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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