GMPs for Equipment, Utilities and Facilities - Online Training Recording
Course No. 21771
Speakers
Dr Jean-Denis Mallet
Former Head of the Pharmaceutical Inspection Dpt. AFSSAPS
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)
Objectives
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.
Background
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.
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 deviations systems of course.
Target Group
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.
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.
Programme
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
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
This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager" Learn more
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