Regulatory Open Forum

I work at a CMDO that manufactures biologic products. A client who is in the process of preparing a BLA is asking for copies of test methods so they can be attached to the applicable control of DS/DP sections (S.4/P.5) - but it seems like this approach would be cumbersome to maintain for us when test methods get revised as we would require us to provide updated copies of the test methods to the client. 

Has anyone dealt with this similar situation? Is this a common practice? I would appreciate to hear any alternative strategies to this as well. 

I work at a CMDO that manufactures biologic products. A client who is in the process of preparing a BLA is asking for copies of test methods so they can be attached to the applicable control of DS/DP sections (S.4/P.5) - but it seems like this approach would be cumbersome to maintain for us when test methods get revised as we would require us to provide updated copies of the test methods to the client. 

Has anyone dealt with this similar situation? Is this a common practice? I would appreciate to hear any alternative strategies to this as well. 

My experience with CBER (OTP) regulated products is that a lot of source documentation is required for the original BLA. Unfortunately there is no current guidance for exactly what should be provided. It is possible to get confirmation at the pre-BLA meeting, but that is quite late in the process and does not guarantee that additional documentation will not be requested.

For a BLA (OTP) it is necessary to provide copies of analytical procedures (SOPs). So, personally I would advise clients to submit detailed summaries in S.4.2 and P.5.2 and provide copies of the SOPs in 3.2.R and for lifecycle management, consider the "registered details" (established conditions) to be the S.4.2 and P.5.2 summaries.

That's my opinion. Hope it helps!

Alexis

I work at a CMDO that manufactures biologic products. A client who is in the process of preparing a BLA is asking for copies of test methods so they can be attached to the applicable control of DS/DP sections (S.4/P.5) - but it seems like this approach would be cumbersome to maintain for us when test methods get revised as we would require us to provide updated copies of the test methods to the client. 

Has anyone dealt with this similar situation? Is this a common practice? I would appreciate to hear any alternative strategies to this as well. 

I agree. Certain Offices like CBER OTP may require submission of method SOPs under 3.2.R and assay validation protocols and reports under 3.2.S and 3.2.P, as applicable, as listed in Guidance https://www.fda.gov/media/87801/download page 3

My experience with CBER (OTP) regulated products is that a lot of source documentation is required for the original BLA. Unfortunately there is no current guidance for exactly what should be provided. It is possible to get confirmation at the pre-BLA meeting, but that is quite late in the process and does not guarantee that additional documentation will not be requested.

For a BLA (OTP) it is necessary to provide copies of analytical procedures (SOPs). So, personally I would advise clients to submit detailed summaries in S.4.2 and P.5.2 and provide copies of the SOPs in 3.2.R and for lifecycle management, consider the "registered details" (established conditions) to be the S.4.2 and P.5.2 summaries.

That's my opinion. Hope it helps!

Alexis

I work at a CMDO that manufactures biologic products. A client who is in the process of preparing a BLA is asking for copies of test methods so they can be attached to the applicable control of DS/DP sections (S.4/P.5) - but it seems like this approach would be cumbersome to maintain for us when test methods get revised as we would require us to provide updated copies of the test methods to the client. 

Has anyone dealt with this similar situation? Is this a common practice? I would appreciate to hear any alternative strategies to this as well. 

Juliane- I don't see where it says in the guidance that actual SOPs, protocols, & reports may be required. Can you please share the exact wording you're referring to?

I agree. Certain Offices like CBER OTP may require submission of method SOPs under 3.2.R and assay validation protocols and reports under 3.2.S and 3.2.P, as applicable, as listed in Guidance https://www.fda.gov/media/87801/download page 3

My experience with CBER (OTP) regulated products is that a lot of source documentation is required for the original BLA. Unfortunately there is no current guidance for exactly what should be provided. It is possible to get confirmation at the pre-BLA meeting, but that is quite late in the process and does not guarantee that additional documentation will not be requested.

For a BLA (OTP) it is necessary to provide copies of analytical procedures (SOPs). So, personally I would advise clients to submit detailed summaries in S.4.2 and P.5.2 and provide copies of the SOPs in 3.2.R and for lifecycle management, consider the "registered details" (established conditions) to be the S.4.2 and P.5.2 summaries.

That's my opinion. Hope it helps!

Alexis

I work at a CMDO that manufactures biologic products. A client who is in the process of preparing a BLA is asking for copies of test methods so they can be attached to the applicable control of DS/DP sections (S.4/P.5) - but it seems like this approach would be cumbersome to maintain for us when test methods get revised as we would require us to provide updated copies of the test methods to the client. 

Has anyone dealt with this similar situation? Is this a common practice? I would appreciate to hear any alternative strategies to this as well. 

On page 10, lines 415 & 416 and on page 11, lines 425 & 426, submitting analytical procedures is mentioned.

Juliane- I don't see where it says in the guidance that actual SOPs, protocols, & reports may be required. Can you please share the exact wording you're referring to?

I agree. Certain Offices like CBER OTP may require submission of method SOPs under 3.2.R and assay validation protocols and reports under 3.2.S and 3.2.P, as applicable, as listed in Guidance https://www.fda.gov/media/87801/download page 3

My experience with CBER (OTP) regulated products is that a lot of source documentation is required for the original BLA. Unfortunately there is no current guidance for exactly what should be provided. It is possible to get confirmation at the pre-BLA meeting, but that is quite late in the process and does not guarantee that additional documentation will not be requested.

For a BLA (OTP) it is necessary to provide copies of analytical procedures (SOPs). So, personally I would advise clients to submit detailed summaries in S.4.2 and P.5.2 and provide copies of the SOPs in 3.2.R and for lifecycle management, consider the "registered details" (established conditions) to be the S.4.2 and P.5.2 summaries.

That's my opinion. Hope it helps!

Alexis

I work at a CMDO that manufactures biologic products. A client who is in the process of preparing a BLA is asking for copies of test methods so they can be attached to the applicable control of DS/DP sections (S.4/P.5) - but it seems like this approach would be cumbersome to maintain for us when test methods get revised as we would require us to provide updated copies of the test methods to the client. 

Has anyone dealt with this similar situation? Is this a common practice? I would appreciate to hear any alternative strategies to this as well. 

On page 10, lines 415 & 416 and on page 11, lines 425 & 426, submitting analytical procedures is mentioned.

Juliane- I don't see where it says in the guidance that actual SOPs, protocols, & reports may be required. Can you please share the exact wording you're referring to?

I agree. Certain Offices like CBER OTP may require submission of method SOPs under 3.2.R and assay validation protocols and reports under 3.2.S and 3.2.P, as applicable, as listed in Guidance https://www.fda.gov/media/87801/download page 3

My experience with CBER (OTP) regulated products is that a lot of source documentation is required for the original BLA. Unfortunately there is no current guidance for exactly what should be provided. It is possible to get confirmation at the pre-BLA meeting, but that is quite late in the process and does not guarantee that additional documentation will not be requested.

For a BLA (OTP) it is necessary to provide copies of analytical procedures (SOPs). So, personally I would advise clients to submit detailed summaries in S.4.2 and P.5.2 and provide copies of the SOPs in 3.2.R and for lifecycle management, consider the "registered details" (established conditions) to be the S.4.2 and P.5.2 summaries.

That's my opinion. Hope it helps!

Alexis

I work at a CMDO that manufactures biologic products. A client who is in the process of preparing a BLA is asking for copies of test methods so they can be attached to the applicable control of DS/DP sections (S.4/P.5) - but it seems like this approach would be cumbersome to maintain for us when test methods get revised as we would require us to provide updated copies of the test methods to the client. 

Has anyone dealt with this similar situation? Is this a common practice? I would appreciate to hear any alternative strategies to this as well. 

I work at a CMDO that manufactures biologic products. A client who is in the process of preparing a BLA is asking for copies of test methods so they can be attached to the applicable control of DS/DP sections (S.4/P.5) - but it seems like this approach would be cumbersome to maintain for us when test methods get revised as we would require us to provide updated copies of the test methods to the client. 

Has anyone dealt with this similar situation? Is this a common practice? I would appreciate to hear any alternative strategies to this as well. 

I work at a CMDO that manufactures biologic products. A client who is in the process of preparing a BLA is asking for copies of test methods so they can be attached to the applicable control of DS/DP sections (S.4/P.5) - but it seems like this approach would be cumbersome to maintain for us when test methods get revised as we would require us to provide updated copies of the test methods to the client. 

Has anyone dealt with this similar situation? Is this a common practice? I would appreciate to hear any alternative strategies to this as well. 

I work at a CMDO that manufactures biologic products. A client who is in the process of preparing a BLA is asking for copies of test methods so they can be attached to the applicable control of DS/DP sections (S.4/P.5) - but it seems like this approach would be cumbersome to maintain for us when test methods get revised as we would require us to provide updated copies of the test methods to the client. 

Has anyone dealt with this similar situation? Is this a common practice? I would appreciate to hear any alternative strategies to this as well. 

Dear Anon,

you should consider a DMF for this. 

I work at a CMDO that manufactures biologic products. A client who is in the process of preparing a BLA is asking for copies of test methods so they can be attached to the applicable control of DS/DP sections (S.4/P.5) - but it seems like this approach would be cumbersome to maintain for us when test methods get revised as we would require us to provide updated copies of the test methods to the client. 

Has anyone dealt with this similar situation? Is this a common practice? I would appreciate to hear any alternative strategies to this as well.