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    Auditing of Vendors

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    Devang Gondaliya
    This document discusses vendor audits and qualification procedures. It defines a vendor as someone who purchases products from manufacturers to sell to customers. Vendor audits evaluate areas like management responsibility and quality control measures to ensure acceptable products. The document outlines procedures for including vendors in approved lists for raw materials and packaging, which involves vendor evaluation, sampling, and ongoing assessment. Vendors can be excluded for failing specifications or other issues, but may later be reinstated after corrective actions.

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    Auditing of Vendors

    Uploaded by

    Devang Gondaliya
    103 views12 pages
    This document discusses vendor audits and qualification procedures. It defines a vendor as someone who purchases products from manufacturers to sell to customers. Vendor audits evaluate areas like management responsibility and quality control measures to ensure acceptable products. The document outlines procedures for including vendors in approved lists for raw materials and packaging, which involves vendor evaluation, sampling, and ongoing assessment. Vendors can be excluded for failing specifications or other issues, but may later be reinstated after corrective actions.

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    Describes about the audit procedure of vendors in pharmaceutical industry

    Original Title

    auditing of vendors

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    This document discusses vendor audits and qualification procedures. It defines a vendor as someone who purchases products from manufacturers to sell to customers. Vendor audits evaluate areas like management responsibility and quality control measures to ensure acceptable products. The document outlines procedures for including vendors in approved lists for raw materials and packaging, which involves vendor evaluation, sampling, and ongoing assessment. Vendors can be excluded for failing specifications or other issues, but may later be reinstated after corrective actions.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    103 views12 pages

    Auditing of Vendors

    Uploaded by

    Devang Gondaliya
    This document discusses vendor audits and qualification procedures. It defines a vendor as someone who purchases products from manufacturers to sell to customers. Vendor audits evaluate areas like management responsibility and quality control measures to ensure acceptable products. The document outlines procedures for including vendors in approved lists for raw materials and packaging, which involves vendor evaluation, sampling, and ongoing assessment. Vendors can be excluded for failing specifications or other issues, but may later be reinstated after corrective actions.

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    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    of 12

    M.Pharm.

    QA (semester -2)
    Subject : AUDIT AND REGULATORY COMPLIANCE

    INTRODUCTION TO
    AUDITING OF VENDORS

    Guided By: presented By:


    Bhoomi Patel Darshan Darji
    CONTENT:

    • Definition of vendor
    • Introduction to vendor
    • Vendor audit
    • Vendor qualification
    (A)Procedure for inclusion of vendor in approved vendor list (raw material)
    (B)Procedure for inclusion of vendor in approved vendor list (Packaging material)
    • Corrective action and preventive action
    • References
    DEFINITION & INTRODUCTION TO VENDOR:

    • DEFINITION OF VENDOR:
    • A Vendor is someone who purchases products from manufacturers or distributors and sells them
    to the customer. As the last person involved in the process of manufacturing and selling goods,
    they sell goods directly to the ultimate customer. So, they have frequent interaction with their
    clients and can maintain a good relationship with them.
    • INTRODUCTION:
    • In manufacturing, factories and industries use suppliers to get there raw materials.
    • These goods should be of quality and standard. Anything bad cannot be used by the company,
    because the end product reaches the customer. If the customer gets poor or damaged product
    then it degrades the image of company and customers will purchase it from other company.
    • Due to these reasons, supplier audits are conducted by giant companies. There are different
    vendors and suppliers who supply goods to companies. It is necessary for company to make a
    systematic check before approaching to any vendor for getting the raw materials.
    CONTINUE…

    • Therefore trained supplier auditor must be recruited. There are certification courses that an individual
    can take to become a supplier auditor.
    • The auditor has thorough knowledge and practical knowledge of how to check and do the audits for the
    vendor's items.
    • There is a checklist which the auditor should follow and comply with.
    • Supplier audits are very essential for the organization.
    • This audit makes sure the quality of the product and also the raw materials are such that it will last for
    long and will not get damaged within short period of time.
    • Vendor evaluation or supplier audits should be done once in a year.
    • In this kind of audit, the vendor's location, the products and his manufacturing unit should be audited
    and checked well.
    • The kind of audit and how many times it should be done depends on the kind of products and service the
    company is using or buying from the vendor.
    VENDOR AUDIT:

    The primary areas that need to be evaluated in a vendor audit are vendor viability, management responsibility and
    system accuracy.

     The main objectives for a vendor audit are to assess the quality management of the whole organization, through its
    procedures and data processes.

     It is an assessment of quality control measures taken by the vendor to assure that their products and services are
    acceptable for business transaction.

    The audit is performed by the representative of purchase department


    i.e.,QA department.
    Some of the important parameters taken into consideration while auditing:
    Vendor Audit- Pharmaceuticals
    • ISO Certifications
    •  USFDA
    •  Documented Quality Policy
    •  Packaging and Labelling Standards
    •  Premises and manufacturing facilities
    VENDOR QUALIFICATION:
    A. Procedure for inclusion of vendor in approved vendor list (raw material)
    • New vendors must be qualified and approved by QA department before regular supply of raw
    materials in following manner.
    (1).  Purchase department will locate the new vendor and find out the details of products
    manufactured / supplied by them.  in case of existing materials, purchase department will provide
    our specification to the new vendor.
    (2).  Purchase department will submit the samples to QA department or R&D department for
    evaluation as per specifications.
    (3).  Samples from 3 consecutive batches of active ingredient should be procured as pre-shipment
    sample along with certificate of analysis.
     (4). After complete analysis of the sample, the analytical report along with the comments of QA
    department shall be sent to purchase department. the vendor will be included in the temporary
    approved vendor list if the samples are meeting the specifications.
    (5).  Purchase department after studying the comments of QA department shall inform the supplier
    for the supply of the material manufactured by them.
    CONTINUE…
    (6) Based on the product compliance and assessment, further procurement of active raw material
    should be continued.
    (7) All the suppliers evaluated by R&D department on the basis of process / product development
    parameters shall be considered as temporary vendors and will be included in temporary approved
    vendor list. 
    (8) vendors recommended by R&D having drug master file number shall be included as temporary
    vendors and based on the performance on commercial supply for production batches, will be
    transferred to approved vendor list.
    B. Procedure for inclusion of vendor in approved vendor list (Packaging material)
    (1)Purchase department will locate the new vendor and find out the details of products manufactured
    / supplied by them.  
    In case of existing materials, Purchase department will provide our specification to the new vendor.
    (2)For printed and primary packaging materials, vendor audit is performed by representative of
    Purchase department, QA department.
    (3)Samples of printed packaging materials if necessary will be submitted to QA department for
    evaluation.
    CONTINUE....

    (4)Purchase department after studying the comments of QA department shall inform the supplier for
    the supply of the material manufactured by them.
    (5)Purchase department shall carefully study the quality aspect and also the quantity and financial
    aspects of the vendor, they are as follows;
    •  Capability of the vendor to supply the required material within the specified period.
    •  Delivery schedule in order not to affect the production cycle.
    (6)Based on the product compliance and assessment, further procurement of packaging material
    should be continued.  
    (7) All the suppliers evaluated by R&D department on the basis of process / product development
    parameters shall be considered as temporary vendors and will be included in temporary approved
    vendor list. 
    Based on the commercial production supply, they will be transferred to approved vendor list and
    shall be considered as permanent approved vendors.
    CONTINUE…

    • Procedure for exclusion of vendor from approved vendor list:

    (1)The vendor shall be disqualified and removed from the approved vendor’s list for the following
    reasons :
    • If a lot does not comply to the specification with respect to critical tests, then the vendor shall be
    disqualified.
    •(The vendor shall be qualified again on further evaluation and investigation.)
    • 3 out of 10 lots fail to comply the specification in a specified period under review.
    • The delivery schedule is not met for 40% supplies
    (2)The rates mentioned in Purchase Order, differs than the rates mentioned in delivery challenge.
    CORRECTIVE AND PREVENTIVE ACTION:

    The vendor, who has been excluded from the approved vendor’s list, may be included again by
    taking following corrective and preventive actions:

    (1) The vendor shall be made aware of the reasons for his exclusion and shall be asked to explain.
    (2)  Head of Purchase and Head of QA&QC shall conduct a audit of the vendor in order to ensure
    that quality system exists in the organization.
    (3) Carry out the discussion on other non-quality issues like delivery schedule and rate, etc.
    After satisfactory compliance of all above points, the vendor shall be included in Temporary Vendor
    List.
    REFERENCE:

    1. Pharmaceutical guidelines web portal.


    2. PHARMAGUIDELINES.COM
    3. WHO web portal.
    4. AUDIT AND REGULATORY COMPLIANCE By Dr . Prem Goel, Pg No: 3.1 to 3.33
    THANK YOU

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