Quality Control
CML strives to promote the concept of "right the first time - every time". Quality control testing is of critical importance due to the nature of our products. Testing at all stages of the process (raw materials, intermediates, and API) is critical, and is the cornerstone of our culture of prevention rather than detection.
The quality effort includes working with our customers to establish specifications, and then developing and implementing modern analytical techniques to ensure those specifications are met consistently.
CML provides a wide variety of analytical support services for the development and manufacturing consistent with the appropriate phase of drug development. Our method development philosophy is “fit for purpose” meaning we will provide the appropriate level of development/validation to support your API based where your compound is in the development cycle, saving you time and money.
CML offers analytical services such as:
- Stability Indicating Methods
- Determination of Residual Solvent
- Determination of Genotoxic Impurities
- Reference/Impurity Standard Qualification
- Cleaning Validation/Verification methods (specific and non-specific)
- In-process Controls
- Forced Degradation and Impurity Identification
- ICH Compliant Stability Program
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