Method validation

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

Which parameters to be performed for method validation of site transfer product of which dossier is already submited and approved ?

As per my knowledge it is partial method validation on which we have only perform the parameters as specificity, ruggudness and precision.

Except above parameters what are the others to be varified? Is there any guideline for that ?

With regards
Bhagyesh trivedi

2

Dear Bhagyesh,

At this moment there is no clear cut guildeline stating the requirement for analytical method transfer. Following are some of the references which I feel will be of some interest to you.

  1. Analytical Method Transfer by Michael E. Swartz, Ira Krull, available here
    http://chromatographyonline.findanalytichem.com/lcgc/Misc/Analytical-Method-Transfer/ArticleStandard/Article/detail/387497
    .
  2. Analytical Method Transfer by Stephen Scypinski, available here
    http://pharmtech.findpharma.com/pharmtech/data/articlestandard//pharmtech/112002/12532/article.pdf
    .

You will be glad to know that the issue (of Analytical Method Transfer) has been included in the WHO graft guildeline on Transfer of technology (can be accessed here:
http://www.who.int/medicines/services/expertcommittees/pharmprep/TOT-Guideline_QAS08259.pdf
). Currently, the requirements for Method transfer are not the same, what used to be few years back.

Hope the information will be of some help.

Thanks.