This is more like it.
WHO ACTUALLY DO THE VALIDATION TEST in a practical situation FDA/GAMP and when?
That's going to depend on which company you are dealing with. Each pharam company has it's own "Validation Group". These people will (eventually) approve the documents that (contractually) you will write (again, which documents those are will depend on the company.)
The FRS and DDS are usually part of the contract.
Usually you will have a FAT/SAT (Factory/Site Acceptance Test), but not always.
I've sometimes writen URS (I shouldn't have, but that's what I was paid to do).
The IQ, OQ can be done as part of SAT, done separately from SAT, or done instead of SAT.
It all depends on the company.
Does the fact to join the GAMP mean that you have to pass auditions (every project / months / year).
No. Unlike ISO certification, GAMP doesn't certify. GAMP just has a Guide for how to write your documents. The guide is pretty broad, and not tailored to control systems, but systems in general.
Let’s go to say that we have a project of an Automation Pharmaceutical Storage, where the pharmaceutics log in, and ask for some pills, and the machine just supply it, regarding the date and everything… You said you have to apply “GMP for everything that affect the quality of the process” is this an example of a situation to apply FDA Laws? …does It depend on the Pharmacy? …. Who decide it?
First of, what you are talking about here is post-manufacturing. So Good Manufacturing Practice (GMP) doesn't apply, exactly. But since this machine that you describe does touch the pills, interacts with them, potentially damages or contaminates them, then, yes, the FDA would be involved.
There are many GxP requirements in 21 CFR, and I'm sure that such a machine would be covered in there somewhere. I'm guessing "Medical Devices", but you'd have to do a bit of research to figure it out. I'm guessing (since I've never done medical devices) that you'd have to have the FDA come in and review all you documentation themselves, rather than any one company's validation department (which in turn would be audited by the FDA).
When you fill all the documentation that is going to be validate, do you have to follow a format that GAMP supply?, does it depend on the Customer?
It will depend on the customer. You certainly won't go wrong if your table of contents matches the one in GAMP 4, but you might not go right either. A pharmaceutcial company may have in place an SOP (Standard Operating Procedure) on how to write a document. THIS is what should be followed, since this is part of the company's Quality Plan to show that everything is done using a method that they have shown (to the FDA) that diminishes risk. If they don't follow their plan, then the FDA gets mad. It doesn't matter if the plan is sensible, or follows GAMP - if they have a plan, you must follow it.
Reading this sentence the questions came for they self … What is ISO Scope? Can you practice ISO normative instead of GAMP? Is GAMP working with ISO? Depend of the Customer? Is some pharmaceutical company working with ISO? Is it something about America and Europe?
Regarding ISO (9000, 9001, 13485, etc): Just as the pharmaceuticals must have a quality plan, so must their vendors. ISO certification proves that you have such a plan, and that you follow it. They are not the only quality plan certifier around (CSIA has one too), and even with ISO, you are still going to be audited by a pharma to get on an "approved vendor" list (before they will even give you a Request For Quote), but it can help.
But it's not required. What is required is a detailed plan which shows how you execute projects; how you select and train your staff to make sure that they are "qualified" to execute a project; how you track changes.
In a practical situation, do you always work with S88, or is the customer who ask you for an own normative based in S88?
S88 is a whole different game. First of, unlike 21 CFR, it's not a compliance standard, but a guideline.
It is simply a tool which allows you to organize your project. Organizing a project based on S88
may help you write a more organized functional spec, which
may lead to a better FAT/SAT/IQ/OQ, both in terms of ease of execution, and assurance of quality. Or it may not - that's going to depend on your overall organization and writing skills, and your understanding of GAMP/FDA requirements.
Sometimes the customer requests that you follow S88. Sometimes they even understand what that means. Sometimes a project lends itself to S88 organization, so you use it. It's just another tool in the kit.
Do you use to follow step by step GAMP Life Cycle, document ting every action or it is just a guideline?
It's just a guidleine. There is no "GAMP 4 Compliance", no audit by GAMP
Does the fact to us S88 mean that you have to pass auditions (every project / months / year).
It's just a guidleine. There is no "S88 Compliance", no audit by ISA to prove that you followed S88
Which is the connection between FDA/GAMP/S88.
None. Different organizations. Different goals (except for GAMP, which was formed to figure out a method to comply with FDA regulations.
