FDA and EMA consideration about standard used for bioanalysis

  • Summary

Both the FDA and EMA documents deal with reference standards of the test compound in a similar way, with respect to the origin of the material and documentation requirements. (e.g., certificate of analysis to identify the test compound, cover storage condition, expiry dates, batch number and purity )

Certificates of analysis is not required for internal standard, but it is necessary to demonstrate that there are no impurities present in the internal standard that may interfere with the measurement of the test compound.

  • Ref. Bioanalysis (2010) 2(5),929-935
  • Reference standard required

Lot numbers, purity, storage, stability, handling and supporting documentation should be monitored and maintained.
Reference standards should be used before their expiration or recertification.
Ref. The AAPS Journal 2007; 9(1) Article 4 (White paper)

Reference standard should be obtained from an authentic and traceable source.
Suitability of the reference standards should be scientifically justified.
A certification of analysis is required to ensure quality, stability, storage condition, expiration date, batch number and purity
DRAFT GUIDELINE ON VALIDATION OF BIOANALYTICAL METHODS (EMA)

  • Internal standard or rare metabolites required

If the full CA is not available, the documented purity information should be obtained.
CA or purity information of internal standards is not always necessary. It needs to be demonstrated that the internal standards dose not interfere with the chromatography of the analyte of interest.
Ref. The AAPS Journal 2007; 9(1) Article 4 (White paper)

The use of certified standards is not needed for IS, as long as the suitability for use is demonstrated.
DRAFT GUIDELINE ON VALIDATION OF BIOANALYTUCAL METHODS (EMA)