What is acceptance criteria for Method Transfter

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

Hi,

What is the acceptance criteria (%RSD or other parameter) for the following in method transfer

Assay by High Performance liquid Chromatography

Assay by Potentiometry

Impurities by High Performance liquid Chromatography

Regards
Srikanth

2

[quote=snagabiru]Hi,

What is the acceptance criteria (%RSD or other parameter) for the following in method transfer

Assay by High Performance liquid Chromatography
2%.
Assay by Potentiometry
2%
Impurities by High Performance liquid Chromatography
10%

Things to remember.

when low level limits are to be compared.

you have to justify statistically.
[COLOR="#008000"]Eg: 0.1% level , you can fix 0.03 is the difference
Above 0.1% level limits, you can fix 0.05 difference.[/color]

Regards,
Bujji Kanchi.

3

Thanks for Information

4

[quote=bujjikanchi][quote=snagabiru]Hi,

What is the acceptance criteria (%RSD or other parameter) for the following in method transfer

Assay by High Performance liquid Chromatography
2%.
[/quote]

But Intermediate Precision in the original laboratory has the limit of 3% RSD. So why would this be tighter at 2% than is required for the original lab?

5

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please check the reference guideline by WHO.

Table 1 of the attachment clearly saying that assay would differ by 2%.

You may keep 3%, Since your Intermediate precision from Originating lab have the limit 3%.

do you find practically the precision or intermediate precision in case of assay deviated more than 2% RSD any where.

Regards,
Bujji Kanchi.

Method Transfer WHO.pdf (153.2 KB)

6

We’re under FDA, not WHO. That’s an ongoing issue, everplace is different, and not so spelled out in black and white.

7

Intermediate precision, % RSD is reported.
Method transfer,% difference is reported.

There is a difference in reporting style of acceptance criteria to one another.

However, USP or FDA does not have any related guidance for this acceptance criteria as far as I know.

We have submitted many ANDAs(USFDA) by adopting WHO acceptance criteria and got the approval for the same.

USP<1224> General chapter “Analytical method transfer” is not addressed any acceptance criteria.

But I am helpless to your query exactly.

Best Regards,
Bujji kanchi.
+91-8008889185.

8

Dear All,

Method Transfer acceptance criteria given below:

For Assay methods:

  1. System suitability should meet as per methodology
  2. % Assay results shold meet as per Specification
  3. %RSD of assay results of each laboratory and two laboratories NMT 2.0.
  4. The absolute difference b/n the laboratories NMT 1.0.

For Impurities:

  1. System suitability should meet as per methodology
  2. % impurity results shold meet as per Specification
  3. %RSD of each impurity results of each laboratory and two laboratories NMT 10.0.
  4. The absolute difference b/n the laboratories based on the impurity limit. impurities below 0.05% comparison is not required.

Regards,
Srinivas.