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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
    May 2012
    Posts
    3

    Post How a new product is introduced in any plant

    If any product is introduced in plant ,should we go through Change Control or is there any another procedure.

  2. #2
    Validation Guru
    Join Date
    Oct 2010
    Location
    Kalundborg,Denmark
    Posts
    1,694

    Default

    Staff, Machinary, Utilities and Quality staff must be fit for the purpose.
    The plant will get various documents and procedures from R&D.
    The introduction of new product is based on Capacity and Suitability of that particular plant to that particular product.
    Various validation studies will be done by the R&D and first 3 batches will be supervised.
    After satisfactory results, R&D will hand over that to the production Department with all the necessary Inprocess controls enabled to the QA and QC teams.
    This process is slow and steady.
    Durga Prasad
    Internal Consultant,Aseptic Process-NNE Pharmaplan
    www.nnepharmaplan.com
    Denmark

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