Packaging validation

Is there any guideline to be followed for packaging validation?

Have a look at this article as a simple example:

This link tells more about packaging equipment validation.
what about the packaging validation as a process? Is there any guideline for the same?

Do you mean shipping configuration validation? Temperature validation of shipped items?

Suppose, if only appearance, leak test are considered for packaged product (in bottle/blister) for validation study, can we say the packaging validation is complete for that product?

Or something additional is required?

Wanted to know whether there are some guidelines regarding the same?

you should validate working ranges as worse case scenario. For examle;
if you seal blisterin at 150-250 Celcius and you r running machine at 20-100 rpm, you should test them like that;
-min temperature (150 C) with max speed (100 rpm)
-max temperature (250 C) withn min Speed (20) then apply IPC tests like appereance of blister, leakage etc.
you can also take stablity samples while taking normal stability test samples.

ur wellcome :slight_smile:

Thanks for the clarification…


Is it a regulatory requirement to perform Packaging Validation as Process Validation?


I’d say yes:

FDA 820.130 Device packaging. Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution.


820.75 Process validation. (a) Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.

and then for 13485: General requirements
The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable

g) the implementation of defined operations for labeling and packaging.

Please, if any one know, tell me that can the same strip sealing machine can be used for capsules and tablets. or they need seperate validation.