3 consecutive batches requirement

COMPUTER SYSTEM VALIDATION (CSV) 21 CFR PART 11
1

Is it regulatory requirment to produce 3 consecutive batches for process validation, if it is can some one provide the reference of FDA/MHRA etc.

If the product is produce once in a year, how it will be validated 3 times or is it saleable in market without producing 3 batches?

2

the product that could be released to the market is the validated one. so, you should perform the process validation first, submit the document to the regulatory agency, and then you can sell your product after they give you the agreement.

3

Dear

If one batch satisfies the spec. its Incident, second is co-incident but when third one taken is VALIDATION

Thanks,

4

Dear,

May be because Three batches draw out the linearity.

5

you should perform the process validation first, submit the document to the regulatory agency, and then you can sell your product after they give you the agreement.

6

There is no legal requirement for 3 batches. If you can show, that your process matches its specifications just using one batch works as well.

7

[quote=ilu]Is it regulatory requirment to produce 3 consecutive batches for process validation, if it is can some one provide the reference of FDA/MHRA etc.

If the product is produce once in a year, how it will be validated 3 times or is it saleable in market without producing 3 batches?[/quote]

I know of products where 1 batch is produced once every few years. You apply concurrent validation.
Also the 3 batches approach is no longer acceptable in at least some countries, like Germany. The relevant guidance is only available in German though
The modern approach is risk based
3 batches are statistically insignificant

8

Dear Mr. ilu,

Here is the answer to your question:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124782.htm#5
.

Read the answer to question no. 5.

I hope you will get the answer.

Thanks.

9

Hi,

This is my first time on the forum. My question is should I and how validate an existing method from the USP? I performed the method in the lab and got the results that meet the acceptance criteria. Could anyone answer my question please?

Thank you

10

Hi,

This is my first time on the forum. My question is should I and how validate an existing method from the USP? I performed the method in the lab and got the results that meet the acceptance criteria. Could anyone answer my question please?

Thank you

11

Compendial methods do not need to be validated, but you do need to verify that you obtain the correct results. The verification depends upon the method. You need to show that you can differentiate between a pass and a fail.