Stability test - primary packaging

[ShaniQA]

Hello everyone,

We are planning to conduct a stability test for a new product.
I was wondering if it is possible to conduct the study for the product packed only with the primary packaging, under the claim that the secondary package has no part in protecting the product.

Thank you,
Shani.

 

[J0anne]

What is the purpose of the secondary packaging?

 

[Ajit Basrur]

Hello everyone,

We are planning to conduct a stability test for a new product.
I was wondering if it is possible to conduct the study for the product packed only with the primary packaging, under the claim that the secondary package has no part in protecting the product.

Thank you,
Shani.

It would be advisable to mimic the same primary and secondary packaging materials for stability. I am not sure why you would not want to include the secondary packaging ?

Refer to Guidance for Industry - Q1A(R2) Stability Testing of New Drug Substances and Products - https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073369.pdf which states that the stability studies should be conducted on the drug substance packaged in a container closure system that is the same as or simulates the packaging proposed for storage and distribution.

And when you refer to the definition of container closure system, its the sum total of primary and secondary packaging.



.

 

[ShaniQA]

Thank you for the reply.
Our product is packed in a syringe as primary packaging, and then entered into aluminum pouch. this pouch is packed into a shelf box. We do not claim the pouch supply additional protection to the product.
We have previous stability tests for other products, packed in the same way.
The reasons why we want to perform the test only for primary packaging is low space in the stability chamber.

In the following document:

NOTE FOR GUIDANCE ON STABILITY TESTING:
STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
(sorry, I am allowed to upload links yet)

I found this in the glossoray section (page 17):
Container closure system
The sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product. A packaging system is equivalent to a container closure system.

Can I use this claim to perform the expiriment only in primary packaging? What do you think?

 

[ShaniQA]

Still need help in this dilemma .. anyone ?

 

[Ronen E]

Still need help in this dilemma .. anyone ?

Assess the risk.

Can the secondary packaging have detrimental effects on product stability (drug in syringe), under your accelerated stability conditions? In real life conditions?

 

[ShaniQA]

Thank you,

I do not want to say the secondary packaging interfering with the experiment (since previous experiments were conducted with secondary packaging), but it does not help protect the product and therefore not needed to determine the stability of the product. In other words, with or without it we get the same results.

(By the way, this is a medical devices).

If so, should I carry out a risk assessment and claim that?

 

[somashekar]

If you are guided by the FDA document or follow the WHO Annex II for the purpose of stability tests at a recognized third party test house, you will have to respect the said container closure system (The one proposed for marketing). Otherwise you may not get the necessary certification from such lab.
If you are proposing to do the same in-house for the reason stated (The reasons why we want to perform the test only for primary packaging is low space in the stability chamber.) ... then this report can be a useful part or can be a considered as supporting information.