USP (United States Pharmacopeia?s) Compliant Packaging Regulations & Process

blindcat · Apr 29, 2008

USP (United States Pharmacopeia’s) Compliant Packaging Regulations & Process

Hey There,

I am not to sure where this is headed, as I am new to this concept, but I though it looked interesting.
I started on a search for USP information, and landed here.
Is there anyone here that knows about USP compliant packaging, and how to work thru the qualification process??

Oh ya,
I'm Blindcat,

I have been in the blown film industry for around 28 years, and worked thru a number of positions.
I am currently working as a medical products engineer for a small company in SE Wisconsin..
I really don't have too much to say so, I will end it at that.

Regards, and nice to meet you all

Wes Bucey · Apr 29, 2008

Re: USP Regulations?

blindcat said:
Hey There,

I am not to sure where this is headed, as I am new to this concept, but I though it looked interesting.
I started on a search for USP information, and landed here.
Is there anyone here that knows about USP compliant packaging, and how to work thru the qualification process??

Oh ya,
I'm Blindcat,

I have been in the blown film industry for around 28 years, and worked thru a number of positions.
I am currently working as a medical products engineer for a small company in SE Wisconsin..
I really don't have too much to say so, I will end it at that.

Regards, and nice to meet you all

Welcome to the Cove! :agree1:

I've copied your post from the "introduce yourself" forum to here for better exposure

Ajit Basrur · Apr 30, 2008

Re: USP ( United States Pharmacopeia’s) Compliant Packaging Regulations & Process.

blindcat said:
Hey There,

I am not to sure where this is headed, as I am new to this concept, but I though it looked interesting.
I started on a search for USP information, and landed here.
Is there anyone here that knows about USP compliant packaging, and how to work thru the qualification process??

Oh ya,
I'm Blindcat,

I have been in the blown film industry for around 28 years, and worked thru a number of positions.
I am currently working as a medical products engineer for a small company in SE Wisconsin..
I really don't have too much to say so, I will end it at that.

Regards, and nice to meet you all

Hi blindcat,

Is your question more towards the finished products ? If yes, refer 21 CFR Part 211.132 - Subpart G--Packaging and Labeling Control

This scetion is about packaging and labelling controls to be followed with regards to packaging.

Pl let us know if this answers your question or else feel free to come back

Scott Catron · Apr 30, 2008

Re: USP ( United States Pharmacopeia’s) Compliant Packaging Regulations & Process.

blindcat said:
Is there anyone here that knows about USP compliant packaging, and how to work thru the qualification process??

If the question is about qualifying a packaging system for use with a USP monographed material, the UPS states:

USP General Notices under "Preservation said:
The container does not interact physically or chemically with the article placed in it so as to alter the strength, quality, or purity of the article beyond the official requirements.

How you prove that is another process. We manufacture topical antiseptics, and if we want to qualify a new packaging system, we run accelerated stability studies so show that the container doesn't degrade the product beyond expected limits - which for USP materials is 85 to 120% of the amount of active ingredient listed on the label.

The sample monograph on the USP website states the same - see the Packaging and storage section.

Ajit Basrur · Apr 30, 2008

Re: USP (United States Pharmacopeia’s) Compliant Packaging Regulations & Process

Hi blindcat,

Some additional sections in USP for Packaging are -

GENERAL CHAPTERS

<661> Containers - Repackaging into Single Use containers

<671> Containers - Permeation

<1135> Packaging - Unit of Use

<1146> Packaging Practice

<1177> Good Packaging Practices

<1178> Good Repackaging Practices

GENERAL NOTICES

Preservation, Packaging, Storage and Labelling

There is also a Guidance Document - Container Closure Systems for Packaging Human Drugs and Biologics

blindcat · Apr 30, 2008

Re: USP (United States Pharmacopeia’s) Compliant Packaging Regulations & Process

To you that have responded to my quandry, thank you very much.
In further review of the requirements of USP I am finding that my primary material providers will be of little help in qualifying resin for this application.
I guess we will have to bite the bullet and qualify their resins.
This looks like it could be a costly, longer project than we expected with all the testing requirements for packaging that contacts active ingredients.

Thanks for your insight.
Blindcat

blindcat · Apr 30, 2008

Re: USP (United States Pharmacopeia’s) Compliant Packaging Regulations & Process

Ajit,

Thanks for the heads up on the information.
Is this contained within a USP document or a FDA docuemnt?
If it is a USP document, where can I get it?

Thanks again.
Blindcat

Scott Catron · Apr 30, 2008

Re: USP (United States Pharmacopeia’s) Compliant Packaging Regulations & Process

blindcat said:
I am finding that my primary material providers will be of little help in qualifying resin for this application.
I guess we will have to bite the bullet and qualify their resins.

This is usually the case. Suppliers don't want to take on the liability of assuring you their materials won't affect your product.

Ajit Basrur · Apr 30, 2008

Re: USP (United States Pharmacopeia’s) Compliant Packaging Regulations & Process

blindcat said:
Ajit,

Thanks for the heads up on the information.
Is this contained within a USP document or a FDA docuemnt?
If it is a USP document, where can I get it?

Thanks again.
Blindcat

USPs can be bought here - http://www.usp.org/products/

USP (United States Pharmacopeia?s) Compliant Packaging Regulations & Process

blindcat

Wes Bucey

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Ajit Basrur

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Ajit Basrur

blindcat

blindcat

Scott Catron

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Ajit Basrur

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