I got an assignement to rewrite our “purchasing procedure” to include a method of decision making if the materials/equipment bought needs to be validated or not.
To this day we just used common sense but we would like to have added in our procedure because the company is growing, which makes it harder to track everything.
The materials bought are often equipment like particle counters and temperature dataloggers.
As I’m fairly new to the world of GMP I do not know where to start.
Thanks in advance for your input.
In my opinion, you need to create a change control/request when you have the need of a new equipment. In that change control/request you simply identify the person responsible for the validation and he/she will answer if the equipment need to be validated or not
Hi Joao, thank you for anwser. One of the big hurdles entails that there is only one person in charge of purchasing. This person gets every request for paperclips to paticle counters.
So I’m also looking for a way to do a first selection.
In that case, i think you just need to define a decision tree:
Does the new equipment/material have potential impact on finished product, manufacturing process, analisys of the product?
If yes, request the opinion of the validation manager. He’s the one who should perform that evaluation (or anyone delegate by him)
You could do this only in the first time you are buying the equipment/material (assuming that you buy exacly the same things from the same supplier everytime)
I would think that every new piece of equipment needs to be validated in some way. If it is entirely new technology to the organisation then it needs a full validation to show the technology works, if a new version of existing equipment then some partial validation to show that particular item works.
Is there a specific chapter or document that outlines steps to be taken when validating a new piece of equipment? I.e. IQ/OQ documents from the supplier. CIP protocols?