“Evaluate your new supplier face to GMP standard”
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.
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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 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 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.
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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 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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What the GMP Supplier Audit in China and Asia is checking
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What is the process for the GMP Supplier Audit in China and Asia
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What customers say
Martin L., Handicraft Importer, Belgium
“We are sourcing using B2B website such as Alibaba because we can find plenty of potential supplier to feed our procurement. On those platform best supplier are presented, but worth are also there. To make sure our supplier is not a scam or a middle men we appointed Asia Quality Control which got an affordable service securing our deposit with a GMP Supplier Audit”
Laurent L., Buying Office, Hong Kong
“The GMP Supplier Audit allowed us to confirm that supplier we were targeting was actually only a middle men with no real asset. The audit spoted the real manufacturer when visiting the premises where production was made. Thanks to the GMP Supplier Audit, we have avoided to send our money to unreliable people”