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Subscribe NewsletterWater Microbial Test Methods: Harmonization vs Optimal Quality Control – Your Choice
Product Id
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600106
Overview: As much compendial test method harmonization as has already occurred with Microbial Limits testing for non-sterile products and raw materials, surprisingly little has occurred with the microbial test methods used for testing water.
Both USP and JP recommend methods in their non-mandatory informational chapters, and USP goes a step further to encourage the user to find the best method for their water systems which may not be a suggested method. EP is prescriptive about the method that should be used, but it is well-known that this method may not be optimal for many water systems because of the long delay in test results which could be identical from faster methods, leaving no room for emerging Rapid Micro Methods. This presentation covers the reasons for diverse types of flora from one type of water to the next, the differences in the compendial water test methods, the advantages and disadvantages of harmonization those methods, the compendial allowances for utilizing alternative test methods, and a scientifically defensible approach to determining the optimal method for a given water system that is acceptable to all regulatory bodies.
Both USP and JP recommend methods in their non-mandatory informational chapters, and USP goes a step further to encourage the user to find the best method for their water systems which may not be a suggested method. EP is prescriptive about the method that should be used, but it is well-known that this method may not be optimal for many water systems because of the long delay in test results which could be identical from faster methods, leaving no room for emerging Rapid Micro Methods. This presentation covers the reasons for diverse types of flora from one type of water to the next, the differences in the compendial water test methods, the advantages and disadvantages of harmonization those methods, the compendial allowances for utilizing alternative test methods, and a scientifically defensible approach to determining the optimal method for a given water system that is acceptable to all regulatory bodies.
Why Should You Attend:
- Is your water test method revealing all the viable bacterial counts in your water?
- Are you missing a significant fraction of those microbial counts and making poor microbial control decisions because of it?
- Are you sure the micro test you are using would be satisfactory during a regulatory inspection from a region other than your "home" pharmacopoeia?
- Is your microbial test method for water taking longer than you can afford to wait for product release or for water system remediation measures?
- Are you releasing product before water system results are available and regretting it?
- Is your laboratory wasting precious resources by performing all the test methods from all compendia in order to be certain that one of the methods is acceptable?
Areas Covered in the Session:
- Water harmonization that has already occurred
- Water Micro Test Method “Dis-Harmonization�
- Biofilm basics and how it develops
- Biofilm diversity in water systems
- Micro Test Method options and evaluation protocol
- The good and bad of Micro Test Method harmonization
- Where Rapid Micro Methods can fit in
Who Will Benefit: This webinar will be valuable for all companies manufacturing Medical Devices, Diagnostics, Pharmaceuticals, and Biologics whose laboratories utilize pharmacopoeial test methods for water system testing. The employees who will benefit include:
- Microbiology analysts who perform water testing
- Microbiology laboratory supervisors and their managers
- QA managers and personnel involved in establishing methods and specifications for water testing
- Regulatory Affairs managers and personnel involved in defending laboratory operations to FDA and EMEA inspectors and outside auditors
- Validation managers and specialists who must specify test functions and acceptance criteria for water system validation programs
- Consultants