CTP’s Draft Guidance on Analytical Testing Methods Validation and Verification for Tobacco Products
CTP’s Draft Guidance on Analytical Testing Methods Validation and Verification for Tobacco Products What You Need to Know Presented by Charlotte Peyton, EAS Independent Consultant. FDA’s December 2021 draft guidance on validation and verification testing methods used...
Environmental Impact Assessments are Required by FDA, NEPA
By Charles Eirkson, EAS Independent Consultant The National Environmental Policy Act (NEPA, 1969), requires that potential environmental impact of actions, e.g., approvals of new drugs, biologics, food additives, be addressed by the U.S. Food and Drug Administration...
Good Auditing Practices, Making the Most of Your Internal Review
Regular and formal internal audits provide a clear, unbiased view of your facility operations and uncover challenges that must be addressed. No matter your FDA regulated industry, having a formal, thorough and documented audit plan will streamline your audit processes …
FDA Issues Draft Guidance on Validation and Verification of Analytical Testing Methods Used for Tobacco Products
On Dec. 21, FDA issued draft guidance for industry entitled “Validation and Verification of Analytical Testing Methods Used for Tobacco Products.” The draft guidance, when finalized, would provide information and recommendations related to the validation...