Out of Specifications Implementation Dates

September 1999

ICH Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products – Step 5

 

May 2000

ICH Q6A: Specifications: Tests Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances – Step 5

 

June 2006

ICH Q3B (R2): Impurities in New Drug Products – Step 5

 

October 2006

ICH Q3A (R2): Impurities in New Drug Substances – Step 5

 

February 2018

ICH M7 (R1): Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risks – Step 5

 

July 2020

Question and answers on ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risks

 

You can check Tox by Design methodology for Out of Specification reassessment, which are duly validated and signed by an European Registered Toxicologist expert.

In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted that Tox by Design is duly accredited for the French Research Tax Credit CIR.

Feel free to contact us using the Quotation Request below to receive a quotation for Out of Specification reassessment, before or after Marketing Authorisation.