Regulatory Open Forum

Dear Members, 

Can the Stability data generated by Feasibility batch (Made by GMP process and designated as " for non human use only") tested by Non-Validated methods (testing protocol, method will be soon validated) be used for Regulatory Submission? If yes, can you provide the exact reference. 

Thank you

Only as supportive not for approval!

Dear Members, 

Can the Stability data generated by Feasibility batch (Made by GMP process and designated as " for non human use only") tested by Non-Validated methods (testing protocol, method will be soon validated) be used for Regulatory Submission? If yes, can you provide the exact reference. 

Thank you

Thank you, Narayana Rao, 

Can you provide me reference for supportive information. 

Thank you

Murthy

Only as supportive not for approval!

Dear Members, 

Can the Stability data generated by Feasibility batch (Made by GMP process and designated as " for non human use only") tested by Non-Validated methods (testing protocol, method will be soon validated) be used for Regulatory Submission? If yes, can you provide the exact reference. 

Thank you

The rationale for supportive data is because what you have already stated: "Stability data generated by Feasibility batch (Made by GMP process and designated as " for non human use only") tested by Non-Validated methods (testing protocol, method will be soon validated)"

Thank you, Narayana Rao, 

Can you provide me reference for supportive information. 

Thank you

Murthy

Only as supportive not for approval!

Dear Members, 

Can the Stability data generated by Feasibility batch (Made by GMP process and designated as " for non human use only") tested by Non-Validated methods (testing protocol, method will be soon validated) be used for Regulatory Submission? If yes, can you provide the exact reference. 

Thank you

Hello Murthy,

The simple answer is no.  The data which is used for submissions should be from validation runs which are using representative products going to market and from representative production runs.  Concerning the reference, this depends on whether you are speaking about medicinal products or medical devices which are contained in various guidance documents - though I do not think you will find something this specific in the regulations.

The rationale for supportive data is because what you have already stated: "Stability data generated by Feasibility batch (Made by GMP process and designated as " for non human use only") tested by Non-Validated methods (testing protocol, method will be soon validated)"

Thank you, Narayana Rao, 

Can you provide me reference for supportive information. 

Thank you

Murthy

Only as supportive not for approval!

Dear Members, 

Can the Stability data generated by Feasibility batch (Made by GMP process and designated as " for non human use only") tested by Non-Validated methods (testing protocol, method will be soon validated) be used for Regulatory Submission? If yes, can you provide the exact reference. 

Thank you