Analysis & validations

-Examples of services

  • Evaluation of analytical requirements
  • Strategy for validations
  • Qualification of instruments
  • Method validation
  • Process validation.
  • Training in validations
  • CRO/CMO identification
  • CRO/CMO management
  • Root cause analysis

Cases

  • Equipment/methods: Following equipment/methods have been qualified/validated: Laser diffraction, XRD, DSC, TGA, FTIR, HPLC, DVS, ELISA, spectrophotometry, refractometry.
  • Analytical requirements: A survey for a department in large pharma company revealed that the results from one of the time consuming “standard analyses” performed in the department were not used by any of the expected internal customers. Thus, the survey surprisingly showed that this analysis was redundant for development.
  • Optimisation:  During validation of assays for determination of protein concentration for a customer, we optimised the validation process by using a scientific bracketing approach. The overall timeline where reduced from expected 12 months to 3 months.
  • Compliance: A validation program, which included qualification of equipment and validation of approximately 50 test methods were to be finalized as fast as possible due to an upcoming inspection. We were responsible for the full program: From training of employees in how to perform validations, planning the work, drafting of protocols/report and finally implementation.
  • CMO Management: A CMO had recuring problems with OOS batches. A visit revealed that one of the mixing processes took place at another speed than used during validation due to “communication problems” between the software and the equipment.  which caused precipitation of the API.

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