Nothing Special   »   [go: up one dir, main page]
Scribd Logo
Upload

Welcome to Scribd!

  • 95 views

    GMP Audit Check List-Water Supply System

    Uploaded by

    Dharmesh Patel
    The document is a checklist for auditing a water supply system used for GMP production. It contains questions to ensure the water treatment plants are properly designed, maintained and operated; that water sources and equipment are regularly checked for contamination; and that monitoring of water quality covers sample size, location, frequency and tests for chemical, microbial and pyrogen contamination. It also asks if records of monitoring results and remedial actions are maintained, and if stored and distributed water is protected from microbial growth.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd

    GMP Audit Check List-Water Supply System

    Uploaded by

    Dharmesh Patel
    95 views1 page
    The document is a checklist for auditing a water supply system used for GMP production. It contains questions to ensure the water treatment plants are properly designed, maintained and operated; that water sources and equipment are regularly checked for contamination; and that monitoring of water quality covers sample size, location, frequency and tests for chemical, microbial and pyrogen contamination. It also asks if records of monitoring results and remedial actions are maintained, and if stored and distributed water is protected from microbial growth.

    Original Description:

    Original Title

    Untitled

    Copyright

    © © All Rights Reserved

    Available Formats

    DOCX, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    The document is a checklist for auditing a water supply system used for GMP production. It contains questions to ensure the water treatment plants are properly designed, maintained and operated; that water sources and equipment are regularly checked for contamination; and that monitoring of water quality covers sample size, location, frequency and tests for chemical, microbial and pyrogen contamination. It also asks if records of monitoring results and remedial actions are maintained, and if stored and distributed water is protected from microbial growth.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    95 views1 page

    GMP Audit Check List-Water Supply System

    Uploaded by

    Dharmesh Patel
    The document is a checklist for auditing a water supply system used for GMP production. It contains questions to ensure the water treatment plants are properly designed, maintained and operated; that water sources and equipment are regularly checked for contamination; and that monitoring of water quality covers sample size, location, frequency and tests for chemical, microbial and pyrogen contamination. It also asks if records of monitoring results and remedial actions are maintained, and if stored and distributed water is protected from microbial growth.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 1

    GMP Audit Check List- water supply system

     To ensure the reliable production of water of the required quality are water treatment plants -

    A. designed and constructed? B. maintained? operated?.

     Are water sources, water treatment equipment and treated water checked for contamination and
    maintained regularly for

    A. chemical? B. Microbial?

     Does the monitoring system cover

    a.     sample size?

    b.    location where samples are taken form?

    c.     frequency of sampling?

    d.   test and specifications including chemical, microbiological and Pyrogen tests?

     Are records of the result of the monitoring and any of remedial action maintained?
     Is the water produced, stored and distributed in such a way to discourage microbial growth?
     Are pressure relief outlets of water storage protected by hydrophobic microbial air filters?
     Method of water for production;

               a. by distillation ? b. by other means(mention the method)? ... ...

     Is purified /Distilled water stored

    a.     in clean, non-reactive, non-absorptive, non-additive containers?

    b.   protected from contamination?

     If it is not recirculated, is it discarded after 24 hours?


     Is there a sampling procedure covering

    a.     location where samples taken?

    b.    sample size?

    c.     frequency of sampling?

    d.   test and specification including chemical and microbiological and perogen tests?

    You might also like