Analytical Method Validations

Analytical Method Validations

Firms that analyze Food or Drug Products must either use the proscribed official analytical methods and equipment, or they must perform an analytical method validation to demonstrate their method and equipment is equal or superior to the official method. B&R has performed method validation programs against the following official methods;

  • United States Pharmacopeia (USP)
  • National Formulary (NF)
  • Food Chemical Codex (FCC)
  • Japanese Pharmacopeia (JP)
  • European Pharmacopeia (EP)
  • American Chemical Society (ACS)

Depending on the specifics we can help you develop and conduct multi-compendia validation programs. All B&R method validation programs meet FDA and compendia method validation requirements, and include testing for such items as

  • Accuracy
  • Precision – Repeatability
  • Intermediate Precision
  • Specificity
  • Detection Limit
  • Linearity
  • Range
  • Robustness

We have found that the most cost effective process is for B&R to develop your validation protocols and provide them to you for execution. We can also train your staff in how to properly execute and document these validations. Once you have executed the testing B&R will review and collate the data collected, prepare a final report and conclusions for approval, and help you collate all the supplemental documentation. If you need help in identifying or approving an outside 3rd party lab we can assist you there as well.