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Types of Validation (Not a routine Ques)

Friends,
Can any body guide me for Validation study in case of Drying, micronising, etc.,.
When we are doing drying validation for example, is it the process of drying we are validating or the dryer in which we perform drying.

Also for which all cases validation is necessary in mentioned below processes:
Micronising
Milling
Sifting
Homogenisation
(pl. note that iam from API manufacturing unit, not from Formulation)

You both qualify the equipment you are using, and validate the process itself in my opinion.

To qualify the equipment you specify it and check you are going to get what you want. You install it to manufacturer’s specifications and in accordance with any other procedures etc. You test it works functionally and across all the ranges you asked for. You may optimise it in order to limit variable parameters to those which make “good” product.

You can only validate the process when you put the hardware together with all operational controls (SOPs etc) and the trained people who will run it, and then use it to make actual products.

This is a very brief outline of the overall process (and makes it look very simple!).

Cat

Actually my point is, if we can validate the equipment then

  1. whats the use of Qualification study
  2. As the equipment is validated, we can dry any product in it. So theres no need of dryiing val for other pdts in that dryer

Is it so. I dont think both dryer & process are being validated at the same time

:wink:
in my opinion, for process validation to start…we must first qualify the equipment that come in use in that process…

The purpose of the qualification study (or studies) is to demonstrate that the equipment is fit for purpose. This shows that it is correctly installed and that it functions correctly and as you expect it to.

They may also help you write good procedures for using the equipment. (As an example, if the start button is a large green push-button, and your procedure says that to start the equipment you depress the yellow lever, your operators may have a problem).

The process validation demonstrates that when the equipment is in its normal production environment, it makes “good” product. So it should look at the equipment, the people operating it and the procedures they follow when operating it, and doing any product testing etc.

Both stages are necessary and will be requested in audits.

However, for simple equipment, none of the stages should take long, or be very difficult.

I disagree that when the equipment is validated you can dry any product in it. Once the equipment is qualified, then you may dry any product in it. But different products will dry quite differently – a sticky, aggregated product will probably take longer than a free-flowing crystalline type one. Drying time will be one element which you could have to prove on a product-by-product basis as part of your process validation stage.

I hope this helps.

Cat

drying vailidation is perfomued is drier

[quote=Biradavolu]Friends,
Can any body guide me for Validation study in case of Drying, micronising, etc.,.
When we are doing drying validation for example, is it the process of drying we are validating or the dryer in which we perform drying.

Also for which all cases validation is necessary in mentioned below processes:
Micronising
Milling
Sifting
Homogenisation
(pl. note that iam from API manufacturing unit, not from Formulation)[/quote]

[quote=Biradavolu]Actually my point is, if we can validate the equipment then

  1. whats the use of Qualification study
  2. As the equipment is validated, we can dry any product in it. So theres no need of dryiing val for other pdts in that dryer

Is it so. I dont think both dryer & process are being validated at the same time[/quote]

Dear
You seem to be confused with term and scope of Qualification and Validation
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, qualification is part of validation.

as per WHO TRS 937
validation protocol (or plan) (VP)
“A document describing the activities to be performed in a validation, including
the acceptance criteria for the approval of a manufacturing process — or a part thereof — for routine use.”