Nikolaus Ferstl, University Hospital of Regensburg
Dr Johannes Krämer, CSL Behring
Markus Multhauf, Senior Consultant GMP-Engineering
Fritz Röder, Merck
This course’s goal is to show how GMP requirements with regard to maintenance and calibration can be met while also taking into account economical constraints. It will be highlighted what the different requirements in the GMP environment are compared to other industries. It will further be shown, what a maintenance system should look like and how operational maintenance should be conducted.
No downtime and no risk to products or patients are the main deliverables, a maintenance & calibration system should ensure. BUT it is also well known that the maintenance budget is among the first to be cut when cost-saving measures are being implemented. But still, a working maintenance system is a clearly written requirement in the pharmaceutical industry as well as in connected industries. See 21 CFR § 211.58 and 67, for example, as well as chapter 3 of the EU GMP Guide. Even as important as official requirements is the companies’ own interest in having high plant availability and in reducing the number of break downs. The same is true for calibration: having manufactured medicinal products with equipment which has exceeded its calibration interval can lead to a recall of all manufactured batches from that time interval, based on the criticality of the measuring device. Reliable systems for Maintenance and Calibration must therefore be in place. Hygiene is another fundamental requirement in the pharmaceutical industry. It is an important aspect of maintenance work, that the equipment is set back to a cleaned operating state after maintenance or calibration, which has to be addressed in training and in the instructions for the maintenance work.
Another GMP specific aspect is the documentation of maintenance and calibration. Very specific requirements from traceability to the four eye or double-check principle exist and must be met. Calibration certificates not meeting GMP requirements are frequent inspection findings, especially when the calibration has been sourced out to a contractor
In this course we will combine the understanding of the regulatory background and the design of a maintenance system as well as the training of practical aspects occurring in the daily maintenance work:
- What are GMP requirements with regard to Maintenance and Calibration?
- What can a maintenance system look like?
- How do I develop and write a maintenance plan?
- How should results be documented
- How are time intervals for calibration and maintenance fixed?
- What must be done when acceptance criteria have not been met?
Examples will help to understand the basic requirements and how they can be fulfilled.
This course addresses the responsible persons for organising and carrying out maintenance and calibration in the plant as well as contractors carrying out maintenance and calibration.
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.
Training Course Documentation and Certificate
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Introduction and regulatory requirements
- Fundamentals and requirements for a maintenance concept
- Impacts on a pharma facility
- GMP-Requirements & advice from guidelines and Standards
- Planning maintenance during the qualification Phase
- General objectives of maintenance, priorities
- Maintenance as part of the life cycle of manufacturing Equipment
- Responsibilities: system owner / operator, technician, quality assurance, contractors
- Evolution of maintenance and current thinking in industry
- Digital systems, computer aided facilities management
Development of a maintenance system in the GMP Environment
- Definition of the maintenance strategy: proactive, reactive, predictive
- Service Levels, Increasing equipment availability, product safety
- System Impact (priority, importance, ranking)
- Inventory of equipment, HVAC, utilities
- Maintenance / service level Matrix
- Controlling limits and ranges, strategy for setting Limits
- Handling of repairs and replacements
- Determining spare part requirements
- Measuring maintenance performance, reports
A Risk-based approach to maintenance
- Internal versus external maintenance
- Are supplier’s instructions for maintenance sufficient?
- Establishing maintenance items by risk Analysis
- Determination of adequate materials to be used
- Evaluation of available GMP documentation to fix intervals
- Deviations, CAPAs
- Maintenance documentation
- Cost savings
Organization of Maintenance
- Maintenance schedule, planned maintenance
- Execution of maintenance, flowcharts
- GMP-compliant documentation, paper based vs.electronic Solutions
- GMP-Logbook, SOP´s, Change Control
- Labeling and marking
- Staff organisation, qualification
- Workflow Management
- Transfer of responsibilities
- Hazard and risk analysis
GMP compliant calibration is a main aspect of maintenance within the pharmaceutical industry. Scope of this presentation is an introduction to the extensive requirements for instrument calibration. Beside a structured calibration system aspects of uncertainty and test equipment for calibration are presented. An example of executed calibration and its GMP-compliant documentation cover aspects of practical experience within this lecture.
- Structure of a GMP-compliant calibration System
- Requirements for measuring devices
- Uncertainty and how to avoid Errors
- Execution of calibration - an example
- Calibration certificates and documentation
- Determination of calibration intervals
Hygiene aspects in maintenance work
- Requirements for tools and auxiliary materials
- Typical weak points in maintenance work
- Sources of contamination:
- Tools and auxiliary devices
- Internal vs. external employees
- Logbooks, SOPs
- Restoring operational readiness
- Case study 1: Use of ladders in clean rooms
- Case study 2: Wipe mop, wash-machine, cleaning water
- Case study 3: Oil sealing for SS-surfaces in clean rooms
Case Study: Maintenance of a pharmaceutical Water System
- Construction of water systems and components requiring maintenance
- Spare parts, intervals
- Special technical features for maintenance and repair
- Ozone + UV lamps
- Seals & Hoses
- 3.1 certification
- IT Security, Remote Maintenance & Life-Cycle
- Vibration analysis, thermography, ultrasonic analysis
Case Study: Maintenance of an HVAC System
- Fundamentals and requirements for an HVAC System
- Main parameter in a cleanroom
- Test procedures and measurement methods
- Execution of maintenance, checklists
- Case study, examples
Maintenance of manufacturing equipment: examples
- Special requirements and tips & tricks
- Filling equipment
“Maintenance 4.0” – Digital & Paperless
- Case study CSL: implemenation of a paperless maintenance System
- Usage of predictive maintenance tools
- Downtime reduction & cost savings
Recording from 28/29 April 2021
Duration of the recording: approx. 10,5 h