Hello Guest! Log In or Register now. Lost Password? Click Here to Reset

Ask About Validation

Loading
Writing & Executing a Software Validation Protocol: Plain and Simple

Writing & Executing a Software Validation Protocol: Plain and Simple


This quick and easy guide describes methods and approaches for writing a validation protocol that can help ensure a thorough validation effort. It also provides some tips and tricks on executing the protocol and documenting the results.

While this book was written primarily for those new to validation projects and the effort required gathering sufficient evidence to support validation claims , experienced folks will likely find nuggets to help improve their efforts.



Results 1 to 2 of 2
  1. 04-13-2012, 12:45 PM #1
    ashvin.acharya
    ashvin.acharya is offline
    Validation Analyst
    Join Date
    Apr 2012
    Posts
    3

    Default Rinse Recovery for API

    Dear All,

    Pls. let me know that, If once we performed Rinse Recovery for any perticular product as per 10ppm MACO & due to change in manufacturing block / MACO / matrix, if we have to Revalidate the cleaning procedure so is there Rinse recovery performed again or we can considar privious correction factor.


    Thanks & Regards,


    Ashvin Acharya
    Reply With Quote Reply With Quote
  2. 04-17-2012, 02:00 AM #2
    cpbhatt
    cpbhatt is offline
    Validation Analyst
    Join Date
    Apr 2012
    Posts
    1

    Default

    In my opinion if your rinse solution or equipment surface type is changed then only recovery study should be again performed.
    Reply With Quote Reply With Quote
« Previous Thread | Next Thread »

Bookmarks

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •  

Forum Rules

SITE MAP

Useful Information

Our Network

Get In Touch with AskaboutValidation

© 2006 - 2012 askaboutvalidation. All Rights Reserved
Single Sign On provided by vBSSO