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