A newly revised ICHQ2 and analytical validations

Description:
Although companies have relied on USP <1225> and ICH Q2(R1), and FDA guidance documents on analytical procedure validations for about 20 years, a lack of ICH guideline on analytical development has been a long standing gap. Furthermore, ICH Q2(R1) is not directly applicable to many of the analytical procedures commonly used in testing of Pharma and Biopharma products such as Near Infrared (NIR) Spectroscopy, potency assays, and qNMR. These concerns have been addressed in the recently published ICH Q2(R2) and ICH Q14 guidelines. This presentation will describe the changes made in revision 2 (R2) of ICH Q2. All section starting from Introduction to Glossary have been updated in R2. The revised version also includes examples of validation tests and the corresponding experimental design for separation based methods (e.g., HPLC, GC, and CE), ICP-OES and ICP-MS as purity tests, dissolution test, quantitative proton-NMR, binding or cell based assays, quantitative PCR, particle size measurement, NIR, and quantitative LC/MS. We will also discuss impacts of the revised Q2 guidance on analytical validations for pharmaceutical drug products.

Speaker: Shreekant Karmarkar - DAT Pharma Consulting, Inc.
Dr. Shreekant Karmarkar leads DAT Pharma Consulting, Inc. to help Life Sciences' companies make headways for their needs in analytical and CMC development, stability testing, quality non-conformities, and CROs/CDMOs management.