I. GMP Audit Service Introduction
If you are a Chinese API or intermediate manufacturer, hoping to get the Chinese GMP Certificate, improve your quality system or pass the clients' audits to get order, therefore you should improve your actual quality system according to the GMP standards to meet the basic requirements. Factory can hardly find all GMP problems by internal audits; but audits from a third party can find GMP problems that factory can't find in internal audits. So perhaps you hope that a third party can take an audit before the formal official/client audit to find out problems that you haven't found in your internal audits, and improve immediately, so as to help you to pass successfully the formal audit.
If you are an overseas company of preparations or APIs who hopes to buy APIs or intermediates from Chinese manufacturers, you need to ensure that the Chinese manufacturers produce according to the GMP standards. At this moment, perhaps you hope that a third party can audit your manufacturers, provide audit service and the audit results can be used as a reference to evaluate the suppliers, thus you can save high travel costs and overcome language obstacle.
We can audit as a third party under your requirements and help you reach the aim.
II. Our GMP Services:
Now we can provide the following 4 GMP services:
1. GMP Audit of Difference Analysis
If you are a Chinese manufacturer who wants to improve your quality system and GMP level, you can choose our GMP audit of difference analysis. Generally speaking, the audit lasts one day. By this audit, we can find weaknesses of your quality system, and the difference between your GMP level and the official requirements. In conclusion, “GMP Audit of Difference Analysis” can show you the way to improve the performance of your quality system.
2.
Pre-audit
If you are a Chinese manufacturer who will have a formal official/client audit, in order to ensure that you can pass the audit, we suggest you choose us to take a pre-audit 2 weeks before the formal official/client audit. By our pre-audit, we can find out the points that should be improved and propose you corresponding methods, so as to ensure that you can pass successfully the formal official/client audit. Moreover, we have many experts in COS/EDMF compilation, who can check up the coordination between the COS/EDMF files and the factory's actual situation. Before the EDQM local examination, you could choose our pre-audit service.
3.
Internal Audit
If you are a Chinese manufacture who is not satisfied with your internal audits, and agrees that you often can't find problems by yourselves just because you are accustomed to do these operations, therefore we suggest you choose our Internal Audit Service, by which you can eliminate these worries and receive our useful suggestions for the problems found in internal audits.
4.
Audit of Contract manufacturers or suppliers
If you are an overseas manufacturer of preparations or APIs who wants to buy from suppliers or produce by sub-contractors, you would like to ensure that the suppliers or the sub-contractors produce according to GMP standards. These suppliers or sub-contractors may be chosen randomly to have an official audit. If they are found having great GMP problems and their production or sales must be stopped, how should you do? In order to avoid this situation, to save high expenses of local audit, and to overcome the language obstacle, you could choose our Third Party Audit Service. We can audit your suppliers or sub-contractors, to ensure that they are producing according to GMP standards. |
