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Making justification whether a process needs validation or not

[FONT=Arial]Looking for direction for the following email:[/font]

[FONT=Arial]Regards[/font]

[FONT=Arial]Dear Graham,[/font]

[FONT=Arial]Very nice to contact you! Please forgive my direct email to you, hope I’m not bothering you a lot in your busy time.[/font]

[FONT=Arial]I got your contact info from the website “askaboutvalidation”. We’re a medical device making company in Shenzhen. Our products are mostly sold in US market. During the process validation activity, we met some questions and would like to kindly ask you for advice. [/font]
[FONT=Arial]1)[/font][FONT=Arial]The basis of making justification whether a process needs validation or not. What processes are special process which need process validation, and what process can be regarded as normal process which does not need validation? During our production, there will be ultrasonic welding of the component, and then the welded assembly will go through 100% leak test. Does the ultrasonic welding need validation here or not?[/font]
[FONT=Arial]2)[/font][FONT=Arial]Label printing process, does the printing process need to go through IQ, OQ, and PQ? [/font]

[FONT=Arial]Kindly looking forward to your reply with many thanks![/font]

[FONT=Arial]Sincerely with Regards,[/font]
[FONT=Arial]Hannah Zhang[/font]
[FONT=Arial]Quality Engineer[/font]
[FONT=Arial]Respironics Medical Products (Shenzhen) Co., Ltd.[/font]
[FONT=Arial]Email: wenzhen.zhang@respironics.com[/font]

[quote=gokeeffe][FONT=Arial]Looking for direction for the following email:[/font]

[FONT=Arial] [/font]
[FONT=Arial]1)[/font][FONT=Arial]The basis of making justification whether a process needs validation or not. What processes are special process which need process validation, and what process can be regarded as normal process which does not need validation? During our production, there will be ultrasonic welding of the component, and then the welded assembly will go through 100% leak test. Does the ultrasonic welding need validation here or not?[/font]
[FONT=Arial]2)[/font][FONT=Arial]Label printing process, does the printing process need to go through IQ, OQ, and PQ? [/font]

[FONT=Arial] [/font][/quote]

As long as these activites form part of your manufacturing process then yes they need to be validated.

In relation to the printing process, what are you printing, if you are printing labels that are attached to product then absolutely this will also have to be validated. How would you proove that the correct product is getting the correct label. Is there a visual inspection stage???

Regards

[quote=gokeeffe][/font]

As long as these activites form part of your manufacturing process then yes they need to be validated.

In relation to the printing process, what are you printing, if you are printing labels that are attached to product then absolutely this will also have to be validated. How would you proove that the correct product is getting the correct label. Is there a visual inspection stage???

Regards[/quote]

Can I confirm the validation here you meant? Does it mean the full validation including IQ, OQ and PQ, or only part of them? For such ultrasonic welding process with 100% leak test inspection afterwards, should we conduct OQ and PQ?

For printing process, we’re printing the product barcode label which will be attached to the packaging box of the product. The labels will be visually inspected when sticking up to the box. What do you mean by the validation here for printing process? Does it include all IQ, OQ and PQ, or only partially?

Thanks with Regards,
Hannah

[quote=hannahzhang]Can I confirm the validation here you meant? Does it mean the full validation including IQ, OQ and PQ, or only part of them? For such ultrasonic welding process with 100% leak test inspection afterwards, should we conduct OQ and PQ?
[/quote]

I cannot tell you exactly what documents you need, this should be stsated up front in you validation plan for the ultrasonic welding process with 100% leak test inspection. As I am not familiar with this process I am reluctant to advise but I’d imagine a full IQ.OQ is desired

What I mean is that if you askthis machine to print the label for product x then it prints the correct label for product x. Personally I would perform some validation testing to ensure that the machine is working accurately.

As you have a visual inspection stage perhaps this can be stated in your intented use and base risk document and reduce the amount of validation testing because of this.

Hope this helps

  1. Ultrasonic welding
    In theory I think the 100% leak test can be considered to be the ultimate PQ test for this equipment/process. You could defend this by preparing a risk analysis on the subject.

  2. Label printer
    State in a URS what you want the printer to print. Prepare a user acceptance test sheet on which you perform a visual check on the print result.

Only if you need dedicated labels with i.e. randomisation for clinical trails a more extensive validation including validation of the randomization software will be required.

Rob

Thanks Rob good point

Thanks for the advise!!

Dear Hannah Zhang

Pls remember one thing only, and that is:

Validation (in short), is to provide a documented evidence that a particular process meets the pre-determined specifications (or pre-determined quality attributes).

Whether this is the case of welding or label printing, as described by one of our friend, that leak test and visual inspection or inspection thru sensor will serve the cause.

Best regards,

SAQIB ALTAF
Head of Quality Operations
Universal Research Group