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MML can provide extensive expertise in the following areas :
METHOD DEVELOPMENT for:
- particle testing or visual inspection
- Instrumental testing
- Process pass/fail determination criteria
- Scale up
- Nearly all aspects of Visual Inspection –vs- Sub-visible
COMPENDIAL METHOD VALIDATION
- Complete Risk Analysis
- Laboratory Test Methods
- Instrumental DQ/IQ/OQ/PQ/MQ
- Coordination of supplier and customer specifications
METHOD INVESTIGATIONS for test results in OOT, OOS, Statistical Analysis
Method Validation
Our Staff has considerable experience in a variety of method and instrument validations on hundreds of different products from injectables to medical devices and implants. We can help you sort through…
When is Method Validation required?
For USP<788>, <789> , <729>; EP 2.9.19, JP or other Compendial related particulate matter test?
How should I interpret the latest FDA Guidance for my product ?”
What are the risks associated with each parameter that should be considered for validation?
What samples or test methods are more probable candidates for method validation?
What specific parameters must or should be tested in System Suitability tests? How often?
What key FDA method validation requirements should be included the validation, and which ones should be qualified routinely ?
What particle concentration determinations should be made for a sample material where none is in the compendia?
What criteria are best applied to medical devices for validation and routine testing limit?
