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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.



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  1. #1
    Validation Analyst
    Join Date
    Mar 2012
    Posts
    6

    Default Water Validation

    Dear Sir,

    Is there any guideline which shows the testing parameters & limits required for raw water & purified water for non sterile API plants.


    Anyone Please guide....

    Regards
    Pradeep Kudeshia

  2. #2
    Validation Analyst
    Join Date
    Jan 2012
    Location
    Indonesia
    Posts
    26

    Default

    Quote Originally Posted by kudeshia View Post
    Dear Sir,

    Is there any guideline which shows the testing parameters & limits required for raw water & purified water for non sterile API plants.


    Anyone Please guide....

    Regards
    Pradeep Kudeshia
    As I know the USP32 and EP 6 shows the testing parameter requires for the purified water

  3. #3
    Validation Guru
    Join Date
    Jan 2011
    Location
    Bangalore
    Posts
    226

    Default

    Hi, Go for WHO Drinking water specification and ISO Specification. The question will be more relevant if you confirm the intended area of compliance (Geographical Location). Thumb rule is Water should be compliant on Demand.

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