Critical Processes

Dear All,

Can anyone quote me what is the exact definition of Critical Processes?

Thanking you,

kvkiran
validation analyst

[quote=kvkiran]Dear All,

Can anyone quote me what is the exact definition of Critical Processes?

Thanking you,

kvkiran
validation analyst[/quote]

Dear Kvkiran,
Critical processes are usually determined by anlayzing process parameters (factors in a process that are controllable and measurable) and their respective outcomes.

I think this may clear your problem

thanks

[quote=kvkiran]Dear All,

Can anyone quote me what is the exact definition of Critical Processes?

Thanking you,

kvkiran
validation analyst[/quote]

Hi Kiran,

Critical process can be defined as any below parameter which would be affect the product during processing into final product,
Safety, Identity, Strength, Purity, yield, and Quality.

Critical process parameter means ,The parameter which directly affect on quality,yield,and validation.

This really is not an easy thing to answer, because, if your are going to say ‘this’ process is critical, are you inferring other processes are not.
Top Degree;
The process that cannot be tested or inspected to verify it is correct. The efficacy of some devices and drugs, would be destroyed by any form of testing, therefore you can only destructively test a sample, and predicatively forecast that the remainder are within or out-with the requirements.
2nd Degree;
From here on I think there are varying degrees of criticality that can only be categorised or separated, using some form of risk analysis.

Alex Kennedy

Processing done under ISO Class 5 environment

[quote=kvkiran]Dear All,

Can anyone quote me what is the exact definition of Critical Processes?

Thanking you,

kvkiran
validation analyst[/quote]

You have 100 bullets in your gun , your target is one birds shooting in a group - this is not critical ,

you have one bullet and one bird same distance - you don’t have chaise , this is critical

if you have any deviation planned or un-planned it will be fail