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  1. #1
    me_av@hotmail.com
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    Default Guidlines on how to write IQ,OQ,PQ and process validation protocols

    dear colleagues

    Atached is a WHO guidelines on how to write IQ, OQ, PQ and process validation. I thought of sharing this with you.

    best regards
    Mediana
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  3. #2
    Forum Creator gokeeffe's Avatar
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    Default

    Excellent post.

    Really helpful

    Many thanks
    Graham O'Keeffe
    CEO and Founder
    Website: www.askaboutvalidation.com
    Forum: www.learnaboutgmp.com

  4. #3
    Validation Analyst
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    Smile

    Excellent. Helpful in many objectives.

    Best Regards,

    Pravat Kumar Tripathy

  5. #4
    raghugsk
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    Default Good One

    Quote Originally Posted by me_av@hotmail.com View Post
    dear colleagues

    Atached is a WHO guidelines on how to write IQ, OQ, PQ and process validation. I thought of sharing this with you.

    best regards
    Mediana
    Thanks for sharing.

    D.Raghavendra.

  6. #5
    Validation Analyst
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    Smile thanks a lot

    I was in need of the information given by u.
    It really helped me a lot.
    thanks a lot..

    Best regards
    Arif

  7. #6
    Validation Analyst
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    Thumbs up thanks

    thanks a lot,
    Regards,

    Ravi.B

  8. #7
    Validation Analyst
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    Mediana,
    Thank you so much. Most of information contained herein is part of what I've been looking for.
    J Musumba

  9. #8
    Validation Analyst
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    Default

    This is WHO's document.
    It's good.

  10. #9
    Validation Analyst
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    Default

    thanks.. A Blessing...I need this...

  11. #10
    Validation Analyst
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    Default

    Thank you , you had given very good information to us.

  12. #11
    Validation Analyst
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    Default WHO protocol

    I just happened onto this document when I most needed it. Thanks for posting it.

  13. #12
    Validation Analyst
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    Thumbs up

    Thanks for sharing,
    Really very much Helpful .

    Regards,
    Prashant M

  14. #13
    Validation Analyst
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    Thanks for sharing!
    It is good information to me!

    ~~~~~~~~~~~~~~~~~~~~~~~~~~~
    I has view quickly,it is a pity that "the examples comprising this Annex were pasted in from original hard copies,
    and are not available in electronic format"

    Appendix 5: Validation protocols contributed by a vaccine manufacturer
    Massachusetts Public Health Biologic Laboratories
    1) Master Validation Plan for the Vaccine Production Facility .............................. 97
    2) Validation of cleaning processes using swabs to sample for residual protein 104
    3) Master File for Validations of Sterile Fill with Tryptic Soy Broth .................. 108
    4) Requirements for Validating Assays in Quality Control .................................. 145
    (the examples comprising this Annex were pasted in from original hard copies,
    and are not available in electronic format
    )
    Last edited by netabc; 10-12-2008 at 06:11 AM.

  15. #14

    Default hello sir, i am unable to to see the guidle pl suggested

    [Atached is a WHO guidelines on how to write IQ, OQ, PQ and process validation. I thought of sharing this with you.
    sir that file not open pl share with me

    best regards
    rakesh

  16. #15
    raghugsk
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    Default

    excellent, thanks for that

  17. #16
    Validation Guru
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    Thumbs up Good trend.

    Its a good trend to share the available guidelines. I request all members to answer a question with valid reference as well.
    Dr. Shahid A Syed
    QA/Validation Specialist
    Penn Pharmaceutical
    www.pennpharm.com

  18. #17
    Validation Analyst
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    Default

    thank you a lot

  19. #18
    Validation Analyst
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    Default

    Thank you so much for this sharing.
    ıt is really useful document for me.
    Best regards

  20. #19
    Validation Analyst
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    Default thanks, my new question

    sir,
    will we done process validation study for clinical trial batches. it is required or not required.
    or
    process validation is requiment for first three commertial batches.
    Pls. clarify

    Anil Saxena

  21. #20
    Validation Guru
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    Default

    Quote Originally Posted by anil saxena View Post
    sir,
    will we done process validation study for clinical trial batches. it is required or not required.
    or
    process validation is requiment for first three commertial batches.
    Pls. clarify

    Anil Saxena
    Process validation guidelines do not address for Clinical trial batches, as these are mostly unique with its process, formulations and batch sizes. So for each trial require a protocol and data need to be generated of its own. However for phase 3 clinical trials the Formula should be established and process must be validated like a commercial batch.
    Dr. Shahid A Syed
    QA/Validation Specialist
    Penn Pharmaceutical
    www.pennpharm.com

  22. #21
    Validation Analyst
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    Default

    Hi Mediana,

    Thanks for posting the useful information on how to write validation protocols...

    Chris

  23. #22
    Validation Analyst
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    Can you send it to me by e-mail because i don't download this attachment?

    My Emai:wzhong2@163.com

    Thank you!

  24. #23
    Validation Analyst
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    Default

    Attached Part 1 of WHO for ur perusal
    Attached Files Attached Files

  25. #24
    Validation Expert
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    Default

    I do not know why people are searching for readymade protocols. Protocols must be prepared by understanding the process, by knowing the quality requirements and knowing your organization's requirement.

    My suggestion is first understand the requirement that may be quality requirement, productivity requirement or any other requirement. Then identify the variables that affect the quality of the products, then make an action plan for controlling the variables, then plan for testing and documenting the test results. Write the objectives, scopes, responsibilites approval and others as per your SOPs.

    This is a simple example of preparing validation protocol.
    PrAwAn DaHal

  26. #25
    Validation Analyst
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    Default Thanks

    Thanks for Sharing guideline

  27. #26
    Validation Analyst
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    Default

    Quote Originally Posted by me_av@hotmail.com View Post
    dear colleagues

    Atached is a WHO guidelines on how to write IQ, OQ, PQ and process validation. I thought of sharing this with you.

    best regards
    Mediana
    Thanks for sharing
    Ravindra Upare
    Warm Regards
    Ravindra Upare

  28. #27
    Validation Analyst
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    Western Europe
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    Red face Thanx

    Thanx,
    just what I needed to find a good template
    regards Conversano

  29. #28
    Validation Analyst
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    Default

    Thanks a lot,
    Regards,

  30. #29
    Validation Expert
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    Default

    Quote Originally Posted by daprawan View Post
    I do not know why people are searching for readymade protocols. Protocols must be prepared by understanding the process, by knowing the quality requirements and knowing your organization's requirement.
    My suggestion is first understand the requirement that may be quality requirement, productivity requirement or any other requirement. Then identify the variables that affect the quality of the products, then make an action plan for controlling the variables, then plan for testing and documenting the test results. Write the objectives, scopes, responsibilites approval and others as per your SOPs.
    This is a simple example of preparing validation protocol.

    I agree 100 %!!!Excellent post!! I think so, like daprawan. Most of people want to write protocols even they never was in the production area! The most important is to protect process, not write protocol just like that, just to be present.

    rgds,

    cubica
    The Head of maintenance Dept. HPH

  31. #30
    Validation Analyst
    Join Date
    Oct 2009
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    Default

    Thanks a lot for the protocol
    thanks,
    SRI

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