FDA filing guidance to add sterilization step for approved drug

#1
Dear Colleagues,
Can anyone point me to the FDA guidance as to what type of filing would be required if a sterilization step is added to an approved drug. Can this be filed as a PAS or would this require a new drug application?
Thank you
 
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v9991

Trusted Information Resource
#2
i assume that you are intending to add "sterilization step" to approved product. i.e,.,
* either you were receiving pre-sterilized material which is now intended to be done inhouse.
* or you were doing sterilization as outsourced activity, which is now intended to be done inhouse.

First :- do you have the sterilization step existing in your facility, and
Second :whether it is prior-approved by agency.
Third :- whether the sterilization has been part of the earlier approved-submission.

- in either case, this will lead to major changes in the process. ( of managing materials or manufacturing process)
Hence this should be categorized as prior-approval changes.


Here's few reference.s,
Changes to an Approved NDA or ANDA
4. Transfer of the manufacture of an aseptically processed sterile drug substance or aseptically processed sterile drug product to (1) a newly constructed or refurbished aseptic processing facility or area or (2) an existing aseptic processing facility or area that does not manufacture similar (including container types and sizes) approved drug products.
would be transferring the manufacture of a lyophilized drug product to an existing aseptic process area where no approved lyophilized drug products are manufactured or where the approved lyophilized drug products being manufactured have different container types and/or sizes than the container of the drug product being transferred. See section VI.C.1.b for recommendations for other manufacturing site changes relating to aseptically processed sterile drug substance or aseptically processed sterile drug product. 5. Transfer of the manufacture of a finished drug product sterilized by terminal processes to a newly constructed facility at a different manufacturing site. Once this change has been approved, subsequent site changes to the facility for similar drug product types and processes may be submitted as a changes-being-effected-in-30-days supplement (see section VI.C.1.a).
Changes to an Approved NDA or ANDA
Q12: What is the recommended reporting category for the addition of a new aseptic filling line for sterile products?
A12: The addition of a new aseptic filling line should be reported in a prior approval supplement (section VI.B.4).
Q3: The guidance recommends notification in an annual report for a change in the container closure system for a nonsterile drug product, based on a showing of equivalency to the approved system under a protocol approved in the application or published in an official compendium. Does “protocol” refer to a comparability protocol or the approved stability protocol?
A3: With respect to the guidance, the term protocol refers to tests, validation studies, and acceptable limits to be achieved to demonstrate the absence of adverse effect on the identity, strength, quality, purity, and potency of the drug from specific types of changes. This type of protocol is often referred to as an equivalency protocol or comparability protocol. The approved stability protocol may be one part of the comparability/equivalency protocol to help demonstrate the absence of an adverse effect.
 
#3
Thank you v9991 for the references.
Please see below responses to the questions:
First :- do you have the sterilization step existing in your facility, and
Second :whether it is prior-approved by agency.
Third :- whether the sterilization has been part of the earlier approved-submission.
First - No sterilization in current facility
Second: Not prior-approved by agence
Third: Not part of approved submission
 

v9991

Trusted Information Resource
#4
Thank you v9991 for the references.
Please see below responses to the questions:

First - No sterilization in current facility
Second: Not prior-approved by agence
Third: Not part of approved submission
Hence therefore this ought to be an submission prior-approval before you put it on market...

independent of above opinion, what is the material-category you are dealing with because, even if its not part of your submission, the sterilization might have been part of the supplier's submission package; an description of situation could throw more light...on specifics... Again I don't see it can impact on above opinion.
 
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drhkp

Registered
#5
Hence therefore this ought to be an submission prior-approval before you put it on market...

independent of above opinion, what is the material-category you are dealing with because, even if its not part of your submission, the sterilization might have been part of the supplier's submission package; an description of situation could throw more light...on specifics... Again I don't see it can impact on above opinion.
Good idea, let me inquire into the supplier submission. Thank you for your help and guidance.
 

v9991

Trusted Information Resource
#6
Thank you v9991 for the references.
Please see below responses to the questions:

First - No sterilization in current facility
Second: Not prior-approved by agence
Third: Not part of approved submission
as there is no sterilization in current facility, the approval of anda would be subject to that critical addition i.e., critical to product and critical to facility related point ==> hence prior approval.
again, i am not aware of any exception for treating the sterilization as anything other than critical operation., hence it would trigger an prior-inspection and prior-submission before approval. ( your specific instance has to trigger such an exception!)
 
#7
as there is no sterilization in current facility, the approval of anda would be subject to that critical addition i.e., critical to product and critical to facility related point ==> hence prior approval.
again, i am not aware of any exception for treating the sterilization as anything other than critical operation., hence it would trigger an prior-inspection and prior-submission before approval. ( your specific instance has to trigger such an exception!)
Checked with suppliers they do not have sterilization step either. In my mind, at a minimum it will be a PAS.
 

v9991

Trusted Information Resource
#8
Checked with suppliers they do not have sterilization step either. In my mind, at a minimum it will be a PAS.
it has to be prior-approval supplement; however, this is leading to another question, is how was process meeting the 'sterility' criteria, unless it is newly introduced target?
 
#9
it has to be prior-approval supplement; however, this is leading to another question, is how was process meeting the 'sterility' criteria, unless it is newly introduced target?
There was no sterility criteria, new process step to be added.
 
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