GMP Supplier Audit in China – Good Manufacturing Practice

Ensure your supplier compliance with GMP standard

“Evaluate your new supplier face to GMP standard”

 

Service Description


  • What

    What is the GMP Supplier Audit in China and Asia

    The GMP Supplier Audit also called Good Manufacturing Practice  Audit, is a Manufacturing Practice supplier qualification operation which is performed during the sourcing phase focusing on aiming to assess the capacity of a supplier to adhere to GMP standard.

    It aims to verify the capacity of your potential new supplier in Asia to adhere to the GMP code of conduct.

    See our Supplier Audit Solutions in Asia

    Why

    Why use the GMP Supplier Audit in China and Asia

    In the context of globalisation and international competition, many companies source labour-intensive goods from developing and newly industrialized countries.

    Good manufacturing practices (GMP) are the practices required in order to conform to guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

    Good manufacturing practices, along with good laboratory practices and good clinical practices, are overseen by regulatory agencies in the United States, Canada, Europe, China, and other countries.

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    When

    When the GMP Supplier Audit in Asia is occurring

    This Supplier Evaluation usually takes place during the sourcing phase, after you have spotted a potential supplier to manufacture your goods and before you send money to them as deposit. It is normally performed during the sorting phase (qualification phase) of suppliers during the sourcing.

    It is important to understand that a supplier not being GMP compliant may take several months to become updated to reach compliance.

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    Where

    Where the GMP Supplier Audit in Asia is taking place

    The GMP Supplier Audit will takes place at the vendor premises. If your source is a manufacturer it will be made at the factory premise. If your supplier is a trading company there are chances that the auditor get invited to perform its audit at the manufacturing area which they cooperate with for production.

    See our Quality Assurance in Asia

    Who

    Who conduct the GMP Supplier Audit in Asia

    The GMP Supplier Audit will be performed by a GMP qualified and certified auditor having being accredited by GMP.

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    How

    How does the GMP Supplier Audit in Asia is performed

    Our auditors analyze and assess the supplier in few steps:

    1. Audit Pre-screening

    Preceding the audit, we ask every processing site to fill in the GMP assessment toward oneself survey. This gives the auditor an early introduction of the industrial facility. We will then send the supplier an arrangement of the greater part of the archives we presuppose throughout the review – either in your local language or in English.

    We likewise require a marked “acceptation form” where you commission us to take pictures of the manufacturing site, conduct private meetings with workers, spare the results in a database, and send the report to GMP parts.

    2. On-Site Audit

    We lead the review on location at vendor premises. We figure out whether the working conditions are conformed to the rules of the GMP principles and check if there are verify if  there is satisfaction of the prerequisites of the SA 8000  standard. The review starts with a commencement meeting, to clarify the point and structure of the test and audit. Our investigators then assess the site, including the produciton area, dorms, and cafeteria, meeting executives and different representatives, and check documentation. At the end of the review, a last meeting is held to explain what is found and how it can be corrected.

    3. Registration and Entry in the GMP System

    After the audit supplier receive a written report in English with the test results – including images of the plant. The test results are then entered inthe GMP Database, so other GMP members can see that you are now successfully GMP certified.

    4. Renewal of Certification

    Should our staff find out during the audit that some conditions have not been met, you are obliged to implement the required corrections as quickly as possible. We will then how effective your measures are during a new on-site audit. We will also document the results of that investigation in the GMP Database.

    5. Repeat Audit after 3 Years

    Your entry in the GMP system remains valid for three years. With a repeat audit, you can extend your certification for a further three years.

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    Checking

    What the GMP Supplier Audit in China and Asia is checking

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    See our GMP Audit Standard

    Process

    What is the process for the GMP Supplier Audit in China and Asia

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    See our GMP Supplier Audit Process

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  • Indicators

    Sourcing Completion Phase
    75

    Risk diminishing estimation
    90

  • Benefits

    • Sort out suppliers you have sourced
      Identify who is reliable and who is not
    • Avoid scamming
      Verify your contact is a real manufacturer
    • Assess working conditions of your vendor
      Verify working environment
    • Identify the real manufacturer
      You will know the real source of your vendor
  • What customers say

    GMP Supplier Audit in Images