Regulatory Open Forum

Hello,

Is it expected to provide floor plans in NDA of a parenteral drug product (aseptic filling)? If yes, where should it be presented in the dossier?

Note:

In FDA's Guidance for Industry, M4Q: The CTD - Quality, chapter 3.2.A.1 (Facilities and Equipment) is applicable for biotech manufacturing only.

Thank you.

Hello,

Is it expected to provide floor plans in NDA of a parenteral drug product (aseptic filling)? If yes, where should it be presented in the dossier?

Note:

In FDA's Guidance for Industry, M4Q: The CTD - Quality, chapter 3.2.A.1 (Facilities and Equipment) is applicable for biotech manufacturing only.

Thank you.

You don't need to provide facilities information, it was long discontinued for all traditional drugs/therapeutic biologics. Be aware some consultants would advise you to provide this, they are outdated! 

Hello,

Is it expected to provide floor plans in NDA of a parenteral drug product (aseptic filling)? If yes, where should it be presented in the dossier?

Note:

In FDA's Guidance for Industry, M4Q: The CTD - Quality, chapter 3.2.A.1 (Facilities and Equipment) is applicable for biotech manufacturing only.

Thank you.

Anonymous,

Please provide an FDA communication to industry stating that floorplans are no longer required in A.1.

Best of luck,

------------------------------
Arvilla Trag RAC
Principal Consultant
CMC Compliance Services
Iron River MI
United StatesCMC Compliance Services LLC

Original Message:
Sent: 18-Feb-2024 18:17
From: Anonymous Member
Subject: Floor plans in NDA

This message was posted by a user wishing to remain anonymous

You don't need to provide facilities information, it was long discontinued for all traditional drugs/therapeutic biologics. Be aware some consultants would advise you to provide this, they are outdated! 

Hello,

Is it expected to provide floor plans in NDA of a parenteral drug product (aseptic filling)? If yes, where should it be presented in the dossier?

Note:

In FDA's Guidance for Industry, M4Q: The CTD - Quality, chapter 3.2.A.1 (Facilities and Equipment) is applicable for biotech manufacturing only.

Thank you.

Hello,

Is it expected to provide floor plans in NDA of a parenteral drug product (aseptic filling)? If yes, where should it be presented in the dossier?

Note:

In FDA's Guidance for Industry, M4Q: The CTD - Quality, chapter 3.2.A.1 (Facilities and Equipment) is applicable for biotech manufacturing only.

Thank you.

Parenteral NDA is not biologicals! No floor plans needed for NDA!

Long time ago, it was decided that pre-approval inspection would cover this topic by the District office not reviewers at the center.

Hello,

Is it expected to provide floor plans in NDA of a parenteral drug product (aseptic filling)? If yes, where should it be presented in the dossier?

Note:

In FDA's Guidance for Industry, M4Q: The CTD - Quality, chapter 3.2.A.1 (Facilities and Equipment) is applicable for biotech manufacturing only.

Thank you.

Agree with Peter and the Anon above who stated parenteral NDA is not a biologic/BLA. Type 1 DMF is not required by the FDA.

Parenteral NDA is not biologicals! No floor plans needed for NDA!

Long time ago, it was decided that pre-approval inspection would cover this topic by the District office not reviewers at the center.

Hello,

Is it expected to provide floor plans in NDA of a parenteral drug product (aseptic filling)? If yes, where should it be presented in the dossier?

Note:

In FDA's Guidance for Industry, M4Q: The CTD - Quality, chapter 3.2.A.1 (Facilities and Equipment) is applicable for biotech manufacturing only.

Thank you.

Hello,

Is it expected to provide floor plans in NDA of a parenteral drug product (aseptic filling)? If yes, where should it be presented in the dossier?

Note:

In FDA's Guidance for Industry, M4Q: The CTD - Quality, chapter 3.2.A.1 (Facilities and Equipment) is applicable for biotech manufacturing only.

Thank you.

There is no need to provide such details as floor plans in an NDA (unless requested, but that is extremely unlikely).   Floor plans are of interest to and Investigator conducting an inspection, but likely of no use to a reviewer.  

Hello,

Is it expected to provide floor plans in NDA of a parenteral drug product (aseptic filling)? If yes, where should it be presented in the dossier?

Note:

In FDA's Guidance for Industry, M4Q: The CTD - Quality, chapter 3.2.A.1 (Facilities and Equipment) is applicable for biotech manufacturing only.

Thank you.

A agree with Peter! Type 1 DMF is no longer required in the US for NDAs.

There is no need to provide such details as floor plans in an NDA (unless requested, but that is extremely unlikely).   Floor plans are of interest to and Investigator conducting an inspection, but likely of no use to a reviewer.  

Hello,

Is it expected to provide floor plans in NDA of a parenteral drug product (aseptic filling)? If yes, where should it be presented in the dossier?

Note:

In FDA's Guidance for Industry, M4Q: The CTD - Quality, chapter 3.2.A.1 (Facilities and Equipment) is applicable for biotech manufacturing only.

Thank you.

A agree with Peter! Type 1 DMF is no longer required in the US for NDAs.

There is no need to provide such details as floor plans in an NDA (unless requested, but that is extremely unlikely).   Floor plans are of interest to and Investigator conducting an inspection, but likely of no use to a reviewer.  

Hello,

Is it expected to provide floor plans in NDA of a parenteral drug product (aseptic filling)? If yes, where should it be presented in the dossier?

Note:

In FDA's Guidance for Industry, M4Q: The CTD - Quality, chapter 3.2.A.1 (Facilities and Equipment) is applicable for biotech manufacturing only.

Thank you.

There is no need to provide such details as floor plans in an NDA (unless requested, but that is extremely unlikely).   Floor plans are of interest to and Investigator conducting an inspection, but likely of no use to a reviewer.  

Hello,

Is it expected to provide floor plans in NDA of a parenteral drug product (aseptic filling)? If yes, where should it be presented in the dossier?

Note:

In FDA's Guidance for Industry, M4Q: The CTD - Quality, chapter 3.2.A.1 (Facilities and Equipment) is applicable for biotech manufacturing only.

Thank you.

Peter Smith,

For a normal NDA I would agree with you, but this question is about an aseptically-filled drug. I do not believe the floorplan requirement for biologics is based on the size of the molecule but rather on the aseptic processing. It therefore stands to reason that floorplans may be necessary for this particular NDA.

Of course, there is always the option to just ask FDA,,,

There is no need to provide such details as floor plans in an NDA (unless requested, but that is extremely unlikely).   Floor plans are of interest to and Investigator conducting an inspection, but likely of no use to a reviewer.  

Hello,

Is it expected to provide floor plans in NDA of a parenteral drug product (aseptic filling)? If yes, where should it be presented in the dossier?

Note:

In FDA's Guidance for Industry, M4Q: The CTD - Quality, chapter 3.2.A.1 (Facilities and Equipment) is applicable for biotech manufacturing only.

Thank you.

I see the 1994 guidance on "Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products" has not been withdrawn, and it does call for a floor plan to be submitted for aseptic manufacturing processes. The 2004 guidance on "Sterile Drug Products Produced by Aseptic Processing" also still refers to the 1994 guidance.

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 19-Feb-2024 12:01
From: Arvilla Trag
Subject: Floor plans in NDA

Peter Smith,

For a normal NDA I would agree with you, but this question is about an aseptically-filled drug. I do not believe the floorplan requirement for biologics is based on the size of the molecule but rather on the aseptic processing. It therefore stands to reason that floorplans may be necessary for this particular NDA.

Of course, there is always the option to just ask FDA,,,

------------------------------
Arvilla Trag RAC
Principal Consultant
CMC Compliance Services
Iron River MI
United StatesCMC Compliance Services LLC

Original Message:
Sent: 19-Feb-2024 11:34
From: Peter Smith
Subject: Floor plans in NDA

There is no need to provide such details as floor plans in an NDA (unless requested, but that is extremely unlikely).   Floor plans are of interest to and Investigator conducting an inspection, but likely of no use to a reviewer.  

------------------------------
Peter Smith
Principal
Smith GMP Consulting
Narragansett, Rhode Island
USA

Original Message:
Sent: 18-Feb-2024 16:15
From: Moad Esa
Subject: Floor plans in NDA

Hello,

Is it expected to provide floor plans in NDA of a parenteral drug product (aseptic filling)? If yes, where should it be presented in the dossier?

Note:

In FDA's Guidance for Industry, M4Q: The CTD - Quality, chapter 3.2.A.1 (Facilities and Equipment) is applicable for biotech manufacturing only.

Thank you.

------------------------------
Moad Esa, M.Sc.
Regulatory Affairs Manager
------------------------------

Correct, sterilization information should be submitted for aseptically filled products in the NDA or ANDA. The 1994 guidance on "Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products" clearly states that floor plans should be included among other information related to the aseptic fill manufacturing process. 

The big difference with a BLA, however, is that the sterilization information for NDA/ANDA is to be included in sections p.3.3, p.3.5, and not in section A.1. A clear outline of where the information should be located in the dossier (ToC) can be found in MAPP 5040.1 on the "Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q)" of 2017. 

------------------------------
Ronald Ullers
Venn Life Sciences
Breda
Netherlands

Original Message:
Sent: 19-Feb-2024 13:07
From: Anne LeBlanc
Subject: Floor plans in NDA

I see the 1994 guidance on "Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products" has not been withdrawn, and it does call for a floor plan to be submitted for aseptic manufacturing processes. The 2004 guidance on "Sterile Drug Products Produced by Aseptic Processing" also still refers to the 1994 guidance.

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 19-Feb-2024 12:01
From: Arvilla Trag
Subject: Floor plans in NDA

Peter Smith,

For a normal NDA I would agree with you, but this question is about an aseptically-filled drug. I do not believe the floorplan requirement for biologics is based on the size of the molecule but rather on the aseptic processing. It therefore stands to reason that floorplans may be necessary for this particular NDA.

Of course, there is always the option to just ask FDA,,,

------------------------------
Arvilla Trag RAC
Principal Consultant
CMC Compliance Services
Iron River MI
United StatesCMC Compliance Services LLC

Original Message:
Sent: 19-Feb-2024 11:34
From: Peter Smith
Subject: Floor plans in NDA

There is no need to provide such details as floor plans in an NDA (unless requested, but that is extremely unlikely).   Floor plans are of interest to and Investigator conducting an inspection, but likely of no use to a reviewer.  

------------------------------
Peter Smith
Principal
Smith GMP Consulting
Narragansett, Rhode Island
USA

Original Message:
Sent: 18-Feb-2024 16:15
From: Moad Esa
Subject: Floor plans in NDA

Hello,

Is it expected to provide floor plans in NDA of a parenteral drug product (aseptic filling)? If yes, where should it be presented in the dossier?

Note:

In FDA's Guidance for Industry, M4Q: The CTD - Quality, chapter 3.2.A.1 (Facilities and Equipment) is applicable for biotech manufacturing only.

Thank you.

------------------------------
Moad Esa, M.Sc.
Regulatory Affairs Manager
------------------------------

Peter Smith,

For a normal NDA I would agree with you, but this question is about an aseptically-filled drug. I do not believe the floorplan requirement for biologics is based on the size of the molecule but rather on the aseptic processing. It therefore stands to reason that floorplans may be necessary for this particular NDA.

Of course, there is always the option to just ask FDA,,,

There is no need to provide such details as floor plans in an NDA (unless requested, but that is extremely unlikely).   Floor plans are of interest to and Investigator conducting an inspection, but likely of no use to a reviewer.  

Hello,

Is it expected to provide floor plans in NDA of a parenteral drug product (aseptic filling)? If yes, where should it be presented in the dossier?

Note:

In FDA's Guidance for Industry, M4Q: The CTD - Quality, chapter 3.2.A.1 (Facilities and Equipment) is applicable for biotech manufacturing only.

Thank you.

Hello,

Is it expected to provide floor plans in NDA of a parenteral drug product (aseptic filling)? If yes, where should it be presented in the dossier?

Note:

In FDA's Guidance for Industry, M4Q: The CTD - Quality, chapter 3.2.A.1 (Facilities and Equipment) is applicable for biotech manufacturing only.

Thank you.

Based on recent submitted NDAs for parenteral NDAs, no floor plans were included and the NDAs were approved. The reviewers relied on the PAI i.e. District Office responsibility to cover this aspect. Reviewers at the center stopped reviewing Type 1 DMF information, those MAPP and guidance documents are old and outdated! I'd focus on the process as more important and reviewers rely on the field office to ensure compliance.

Hello,

Is it expected to provide floor plans in NDA of a parenteral drug product (aseptic filling)? If yes, where should it be presented in the dossier?

Note:

In FDA's Guidance for Industry, M4Q: The CTD - Quality, chapter 3.2.A.1 (Facilities and Equipment) is applicable for biotech manufacturing only.

Thank you.

Anonymous,

Were any of the NDAs you submitted without floorplans for aseptically filled parenterals? The "old and outdated" MAPP Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q) was reissued 07 Dec 2022, and it specifically requires floorplans for aseptically filled parenterals.

------------------------------
Arvilla Trag RAC
Principal Consultant
CMC Compliance Services
Iron River MI
United StatesCMC Compliance Services LLC

Original Message:
Sent: 20-Feb-2024 07:46
From: Anonymous Member
Subject: Floor plans in NDA

This message was posted by a user wishing to remain anonymous

Based on recent submitted NDAs for parenteral NDAs, no floor plans were included and the NDAs were approved. The reviewers relied on the PAI i.e. District Office responsibility to cover this aspect. Reviewers at the center stopped reviewing Type 1 DMF information, those MAPP and guidance documents are old and outdated! I'd focus on the process as more important and reviewers rely on the field office to ensure compliance.

Hello,

Is it expected to provide floor plans in NDA of a parenteral drug product (aseptic filling)? If yes, where should it be presented in the dossier?

Note:

In FDA's Guidance for Industry, M4Q: The CTD - Quality, chapter 3.2.A.1 (Facilities and Equipment) is applicable for biotech manufacturing only.

Thank you.