Filling Lines PV

GOOD VALIDATION PRACTICE (cGVP)
1

Hi!

If I have one product that can be filled by a Tube Filling Machine and a Bottle Filling Machine and I have 2 Tube Filling Machines and 3 Bottle Filling Machines.

Do I do a PV for all the 5 filling machines or just select 1 Tube Filler and 1 Bottle filler to represent?

Cheers,

Loke

2

[quote=KY Loke]Hi!

If I have one product that can be filled by a Tube Filling Machine and a Bottle Filling Machine and I have 2 Tube Filling Machines and 3 Bottle Filling Machines.

Do I do a PV for all the 5 filling machines or just select 1 Tube Filler and 1 Bottle filler to represent?

Cheers,

Loke[/quote]

Dear KY_LOKE,
I would suhhest in this case that your process validation should be performed in terms of (Filling-) Packaging Validation. You are bound to conduct a Performance Qualification for every filling-packaging line in your site. Therefore, I would perform a Process Validation for the manufacturing of my product and for the filling-packaging step of each line I would encorpate it to the Performance Qualification of each line for three runs of the same product.
The PQ reference Protocol and Report I would state it to my PV and connect one another.

Please feel free to ask if you need any clarifications.

Best regards,

3

Thank you for sharing.

I have 2 types of product (cream and liquid), and to cover 5 Filling-Packing Lines and with 3 repeats, it will be 30 Validation exercise.

I was trying to reduce the test plan. Any suggestion?

Cheers,

Loke

4

[quote=KY Loke]Thank you for sharing.

I have 2 types of product (cream and liquid), and to cover 5 Filling-Packing Lines and with 3 repeats, it will be 30 Validation exercise.

I was trying to reduce the test plan. Any suggestion?

Cheers,

Loke[/quote]

Dear loke
you are still confused with Process Validation of product and Qualification of Machines. You first go for all equipment/filling and packing machines qualification, perform capability studies and include that in performance qualification. After that you would be able to go for individual product process validation, that will be done typically with 3 commercial scale batches. for further clarification see WHO TRS 937 “Validation and Qualification” Annexure 4 Relationship between validation and qualification;
Validation and qualification are essentially components of the same concept.
The term qualifi cation is normally used for equipment, utilities and systems,
and validation for processes. In this sense, qualifi cation is part of validation."

5

Ok, Good info from you again.

The discussions in this forum is very helpful.

Thanks all.

6

Hi KY
You may be able to reduce the number of PQ’s by running a batch on each machine if:

  1. your packaging lines are of the same make and model
  2. you can justify their similar performance

YL Loke
tech5389@hotmail.com

7

Can a PQ be done on the cartoning machine if the bottles are feed in manually by the operator?