Determination of Triethylamine (TEA) Protocol | IVT

When writing and implementing a protocol, its important to: 

  • Utilize a 2nd analyst and if possible a 2nd instrument and column
  • Include people that will be involved in running the method in the validation
  • Define suitable chemicals and equipment
  • Before signing protocol have 2nd analyst review
  • Review time requirements
  • Make as clear as possible
  • Use the protocol as a template
  • Define the pass/fail criteria and list if the run fulfills the criteria
  • Include example chromatograms/spectrograms/pertinent information
  • Outline full information on equipment used, chemical lots, columns, etc.
  • Detail the notebooks where the information is stored, ensure they are completed
  • List where the data files are stored
  • Create validation pack including spreadsheets, calculations, copies of notebook pages
  • Have a 2nd analyst review before sending for signatures to complete

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