Environmental Monitoring - Trending, Analysis and Data Management
Barcelona, Spain
Course No 17795
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Costs
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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org
Speakers
Dr Raphael Bar, BR Consulting
Sinéad Cowman, Lonza
Michael Schiffer, Novartis Stein
Sinéad Cowman, Lonza
Michael Schiffer, Novartis Stein
Objectives
This practical course will first present the basic methodology of evaluating the Environmental Monitoring (EM) data using elementary Statistical Process Control (SPC) tools as well as empirical approaches to set microbial control limits for clean rooms. This course will address the following issues:
- Overview of controlled rooms classifications, elements of an EM program and present EU and FDA regulations including the recent ISO 14664 changes
- How to organize and present an abundant amount of microbial data in meaningful Graphs
- How to draw useful Control Charts with this data, using the software program Minitab© 19
- To understand how action and alert control limits are set
- How to demonstrate that the environmental microbial monitoring process is under a state of control
- How to calculate and plot the newly proposed Contamination Recovery Rates in USP Chapter <1116>
- How to detect a trend in the environmental microbial monitoring process
- How to apply risk assessment in investigations
All above issues will be demonstrated on examples and case studies of microbial counts generated in controlled rooms of manufacturing facilities of sterile products.
Please note that a laptop is needed for the practical exercises. Also, the “Minitab 19” software must be installed on this computer to solve exercises and generate control charts. You can download a free 30 days trial version of this software here: https://www.minitab.com/en-us/downloads/
Background
Regulatory agencies require from manufacturing companies of pharmaceuticals and biopharmaceuticals, particularly of sterile drug products, to maintain an environmental monitoring program, whereby particulates as well as microorganisms in either air samples (active and passive sampling) or in surfaces (contact plates) are routinely tested and monitored.
Thus, a multitude of environmental microbial data is generated on a routine basis and it is recorded in a manner permitting trend evaluation. But collecting EM data is only the first challenge. The following challenge for the responsible person in quality is charting, analyzing data, setting action and alert limits, interpreting the overall monitoring process behaviour, detecting a trend or shift in contamination levels, monitoring excursion rates and contamination recovery rates, while conducting an ongoing risk analysis. According to the recent revision of EU Annex 1 (Dec. 2017), results from monitoring should be considered when reviewing batch documentation for finished product 1638 release. Therefore, this course is aimed at providing empirical tools for charting and trending EM data.
Thus, a multitude of environmental microbial data is generated on a routine basis and it is recorded in a manner permitting trend evaluation. But collecting EM data is only the first challenge. The following challenge for the responsible person in quality is charting, analyzing data, setting action and alert limits, interpreting the overall monitoring process behaviour, detecting a trend or shift in contamination levels, monitoring excursion rates and contamination recovery rates, while conducting an ongoing risk analysis. According to the recent revision of EU Annex 1 (Dec. 2017), results from monitoring should be considered when reviewing batch documentation for finished product 1638 release. Therefore, this course is aimed at providing empirical tools for charting and trending EM data.
Target Group
- Environmental Monitoring personnel in facilities of pharmaceuticals, biopharmaceuticals and medical devices
- Microbiologists, Quality Assurance personnel, Regulatory Affairs personnel, Production Managers, QC Managers, Senior Management
Programme
Introduction to Charting and Trending
- QbD and trending
- Run Chart vs. Shewhart Control Charts
- Control charts of grouped data versus of individual data
- Examples of microbial charts: grouped vs individual counts
- Variables versus attributes charts
- Poisson and Binomial control chart
- Common cause variation vs. Special Cause (Assignable) variation
- State of control
Regulations on Environmental Monitoring
- Overview of current regulations
- Draft Annex 1
Variability of Data
- Standard deviation of a sample and of population
- Histogram
- Standard deviations of the mean Range
- Relation between standard deviation and Range
- Short-term variation versus global variation
- Separating the signal from noise
Exercise: Calculation of within-group and global Standard Deviations
Control Charts of grouped Data
- Plotting Run chart and control Chart (Process Behaviour Chart)
- Computation of three-sigma Control limits
- Control charts of average, range and standard deviation
Brief Acquaintance with Minitab© 19
- Basic structure of Minitab software
- Drawing a Control Chart
Control Charts of individual microbial Counts
- Moving range (mR)
- Control charts of individual data (XmR)
- Calculation of control limits
- The three-way chart
- Examples of three-way charts
Exercises: Building with Minitab Control Charts of Microbial Counts from passive and active Air Sampling
Data Strategies and Environmental Monitoring – MODA System
Data Strategies and Environmental Monitoring – MODA System
- Data requirements for the evaluation and selection of an electronic system
- How to maximise the value of your data
- Trend analysis tools and tips
- Setting alert and action limits
- Data integrity issues
Environmental Monitoring Program to gain strong Data
- Practical aspects of Environmental Monitoring
- How to set up a structured EM program and gain strong data
- Risk based approach
- Handling of big data amounts
- EM program examples from Industrial clean rooms
Contamination Recovery Rates
- Contamination recovery rates (USP approach <1116>)
- Plotting recovery rates and excursion rates
- Limits of rates versus actual values
- Calculations of contamination recovery rates per USP <1116>
Distribution-free Approach
- Disadvantages of the distribution-based approach
- Non-parametric percentile as control limit
- Tolerance intervals limits
- Shewhart approach for setting control limits
Exercises of percentile determination, plotting of Laney’s charts, Calculations of Contamination Recovery Rates per USP <1116>
Trending Tool Applications
- Trending tool examples from industries
- Data collection tools
- Reaction and measures on negative trends
- Responsibilities
General Approach to Microbial Monitoring
- Overall strategy for microbial monitoring
- Plotting Contamination recovery rates
- Laney’s charts
Exercises: Control Charts of Microbial Counts of active Air Samples in Area Grade B and Contact Plates in Area Grade C; Determining Alert Limits with the Methods of Percentile and Confidence Intervals
Exercise on Trending Tool Applications
Exercise on Trending Tool Applications
- Case studies of evaluation of EM Data
- Use of supportive data
Strategy for detecting a trend and for Continuous Improvement
- Phase 1 and Phase 2 in process monitoring
- Statistical Control of a process: Is your EM process predictable?
- Nelson rules
- Trending and continued process verification
- Trending for Annual Product Review document
- Example of detecting a shift in microbial counts
GMP Conferences by Topics
- Quality Assurance
- GMP in Biotechnology
- Microbiology
- Regulatory Affairs
- GMP in Pharmaceutical Development
- Quality Control
- GDP
- Sterile / Aseptic Manufacturing
- Computer Validation
- Validation
- Technical Operations
- GMP for APIs and Excipients
- Medical Devices
- GMP Basic Training Courses
- Packaging
- Data Integrity