GCC Virtual Closed Forum on CoA White Paper

11am to 12pm EST, October 14, 2020, Virtual

Practical & Straightforward Recommendations on Bioanalytical Certificate of Analysis (CoA) from GCC - Live Discussion on the draft GCC White Paper on CoA

Working Team: Joe Bower, Edward Tabler, Stacie McCown, Jennifer Zimmer, Shane Karnik

The goal of this working team is to provide recommendations allowing for consistent information and level of detail that should be provided within all COAs pertaining to both small and macromolecule reference materials.

The main topics the team will cover in the White Paper related to common deficiencies encounter in COAs:

  • Deficiency in Molecular Weight and Form Information:
  • Deficiency in Purity and Concentration Information:
  • Deficiency in Expiration or Retest Date Information:
  • Deficiency in Storage Condition and Special Handling Information:
  • Other Miscellaneous Deficiencies of COAs:

Below is the final draft of the recommendation from the working team to be included in a COA which includes all of the key components of the COA truly needed to ensure proper use and handling of the material.

Name of Material
  • The compound name should match between what is stated on the COA and what is stated on the vial / tubes provided.
  • If name on vial/tubes is different than compound name on the COA or if the compound is known by alternative names, a comment should be included in the COA to make the connection.
Source
  • The manufacturer, source, origin of the compound should be provided.
Batch / Lot
  • The batch or lot number should match between what is stated on the COA and what is stated on the vial / tubes provided.
Storage Condition
  • The storage condition of the compound in the form which is being provided, or the storage condition of the compound for its intended use if its provided in lyophilized form with clear instructions for reconstitution and buffers to be used.
  • Other pertinent information required for handling must be provided; such as container material, not exposed to UV light, under inert gas, with desiccant present or any other special handling instructions (i.e. dry before use).
Expiration / Retest
  • Expiration date of the compound in the form provided, or retest date of the compound in the form provided should be clearly stated.
Purity
  • Purity of the compound in the form provided should be clearly stated on the COA or the purity percentage to be used for correction factor calculations should be provided.
  • If multiple measurements have been used for purity determination, the main purity factor to be used should be clearly stated.
Concentration
  • Concentration of the compound in the form provided should be clearly stated on COA. If the compound requires reconstitution, clear instructions for reconstitution should be provided as well as the buffers required for reconstitution and the final concentration after reconstitution should be stated.
  • If any additional testing would be required to verify successful reconstitution, tests should also be clearly stated with acceptance criteria.