Advise on Oral Spray Pad Printing and Compliance

C

Chintan.shah

#1
Hello

I am working on the combination product (oral spray) made up of PP molding casing and glass bottle containing Drug.

All the above parts, drug and assembly is done in control room(Air controlled, protective clothing, gloves, caps, etc.)

Now I have requirement to do the pad printing(Third party) on the molded parts before assembly process.

I would like to know following things,

1) Do the pad printing need to be done in controlled environment as this product is oral spray and will not be sterilized?

2) If pad printing will be done in non GMP area, how I can justify the product will be produced in GMP.

3) Is there any FDA standards around printing on the polypropylene parts and what will be needed to test compliance with those?

4) and is there any process can be carried out on pad printed parts to reuse them in controlled environment? (like UV curing or sterilization or cleaning)

Sorry for create one thread for all queries, but they are related to each other.

Any response with practical example is highly appreciated.

Many Thanks in Advance.

Regards
Chintan
 
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Ronen E

Problem Solver
Staff member
Moderator
#3
Re: Advise on the Pad Printing and compliance

1) Do the pad printing need to be done in controlled environment as this product is oral spray and will not be sterilized?
IMO yes, if your risk evaluation shows that there's an unacceptable risk of contamination from the uncontrolled printing environment ending up in the patient's oral cavity or its surrounds.

2) If pad printing will be done in non GMP area, how I can justify the product will be produced in GMP.
You will have to analyse all the implications of working under non-GMP conditions and account for each one that is significant (i.e. poses an unacceptable risk). For instance, if there is an unacceptable risk of contamination, perhaps a secondary cleaning operation (to be validated) will be required right before the parts enter the GMP environment for further assembly.

3) Is there any FDA standards around printing on the polypropylene parts and what will be needed to test compliance with those?
I can't recall, off the top of my head, a specific one that is directly related, but it's likely that there are some relevant guidance documents (covering various aspects of clean manufacturing). One way to know is to run general searches on FDA's website, and review the results for relevance, one by one. Another is to contact the FDA and ask.

Please note that if the print might come into contact with the patient's mouth you will have to account for it in your biocompatibility evaluation. Additionally, FDA has specific regulation concerning colourants, that you must comply with.

4) and is there any process can be carried out on pad printed parts to reuse them in controlled environment? (like UV curing or sterilization or cleaning)
If your concern is incomplete curing then post-curing may be relevant. If cleanliness is the issue, cleaning (not necessarily sterilization) would be your focus. It depends on what the risks are.

Cheers,
Ronen.
 
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