Environmental Monitoring Data Management
Berlin, Germany
Course No 16693
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Speakers
Dr Raphael Bar, BR Consulting
Michael Schiffer, Novartis Pharma Stein, Switzerland
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®18
- 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>
- 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.
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 behavior, detecting a trend or shift in contamination levels, monitoring excursion rates and contamination recovery rates, while conducting an on-going 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
PLEASE NOTE
A laptop with Excel© is needed for the practical exercises. Also, the “Minitab” software must be installed on this computer to solve exercises and generate control charts. You can download a 30 days trial version of thissoftware here:
https://www.minitab.com/en-us/products/minitab/
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
- Overview of current regulations
- Revised Annex 1
- Practical aspects of Environmental Monitoring
- How to set up an structured EM program and gain strong data
- Risk-based approach
- Handling of big data amounts
- EM program examples from Industrial clean rooms
- 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
Control Charts of grouped data
- Plotting Run chart and control chart (Process Behavior Chart)
- Computation of three-sigma Control limits
- Control charts of average, range and standard deviation
- Basic structure of Minitab software
- Drawing a Control Chart
- Moving range (mR)
- Control charts of individual data (XmR)
- Calculation of control limits
- The three-way chart
- Examples of three-way charts
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>
- Disadvantages of the distribution-based approach
- Non-parametric percentile as control limit
- Tolerance intervals limits
- Shewhart approach for setting control limits
Trending Tool applications
- Trending tool examples from industries
- Data collection tools
- Reaction and measures on negative trends
- Responsibilities
- Overall strategy for microbial monitoring
- Plotting Contamination recovery rates
- Laney’s charts
Investigation and Risk Assessment
- Case studies of evaluation of EM Data
- Use of supportive data
- 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
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