BlogsTag: Regulatory News
Working document QAS/16.671: GUIDELINES ON VALIDATION - APPENDIX 4: ANALYTICAL METHOD VALIDATION
Blog: Site News | Posted By: Denyse Baker | Released: June 28, 2016, 11:32 am
WHO released the latest in their series of draft guidelines related to validation today. PDA is soliciting volunteers to help develop a response to this draft appendix 4 on Analytical Method Validation. Please contact Denyse Baker (email@example.com) if you are interested and available to participate.
FDA Final Guidance on Elemental Impurities - ICH Q3D - is adopted.
Blog: Site News | Posted By: Janeen Skutnik-Wilkinson | Released: September 10, 2015, 5:33 am
FDA Finalizes ICH Q3D guidance establishing permitted daily exposures for 24 elements in drug products based on evaluation of tox data.