• Introduction of COS (CEP): The COS (Certificate of Suitability for European Pharmacopoeia) is a conformity certificate awarded by the EDQM to prove that the produced API conforms to the requirements of Ph. Eur.. 34 Members of the EDQM and the whole EU recognize the COS and think it is the most basic demand to import APIs to European market.
Compared with EDMF procedure, API manufactures can apply for COS independently to the EDQM. The content includes detailed information of: manufacturing process of API, in-process control, characterization, chemical properties, quality control and stability, etc., especially impurity study. Therefore COS registration is the best choose for API manufacturers for exportation.
• Our COS Registration Service:
In 1999, we started our COS registration services. Till now, we have successfully registered COS for many Chinese pharmaceutical companies and obtained 10 COS , including fermentation, semi-synthesis and synthesis products, etc.
• Our Successful Cases in COS Registration:
| Product |
COS Number |
| ASPIRIN |
R0-CEP 2001-210-REV 01 |
| EPHEDRINE HCl |
R0-CEP 2002-193-REV 00 |
GRISEOFULVIN |
R0-CEP 2002-143-REV 00
|
|
R0-CEP 2000-295-Rev 02 |
| OTC BASE |
R0-CEP 2002-035-REV 01 |
| OTC HCl |
R0-CEP 2002-118-REV 01 |
PROGESTERONE
|
|
|
R0-CEP 2002-217-Rev 02 |
| VITAMIN B12 |
R0-CEP 2003-233-REV 00 |
| CABAMAZEBINE |
R0-CEP 2002-221-REV 00 |
Note: Till the end of March 2004, EDQM has totally delivered 1520 CEP. 970 of them are of chemical products certificates, occupying 63.8% of total; 430 are of biological material certificates which should be done TSE assessment evaluation, occupying 28.28% of total; 43 certificates that have both of them, occupying 2.82%; 75 cancelled certificates, occupying 4.93%; 1445 valid certificates. In China , there are only 45 CEP, held by 24 pharmaceutical enterprises; among them, 2 certificates are cancelled; the number of valid certificates is 43, only occupies 2.97% of the total certificates delivered in the world.
Our advantages in the COS Registration Service:
We have an expert team. They will work all along the procedure of the COS registration, till our client obtains the COS.
Our headquarters in France : Our Doctors of Pharmaceutics and senior experts will be in charge of the documents' examination, submission and tracing. They will also contact and discuss with the European officers directly.
Our Chengdu office: Our professional team is responsible to contact with Chinese factories and to compile the application files.
Laboratory center: we have established a laboratory in Sichuan University . Our experts of pharmaceutical analysis are in charge of the impurities experiments for COS registration.
Audit team: we have a professional QA team; they make Third Party GMP Audit to the API manufacturers.
The quality of application files is ensured by our wealth of experience and our independent laboratory center; so the period of application is effectively shortened.
The procedure of our COS registration service:
1) Establish the intension of cooperation with the API manufacturer; confirm the relationship of client-agent.
2) Provide an outline for compiling the application file to the client.
3) Introduce knowledge of COS registration and information about GMP from ICH to the client.
4) The client offers original documents in Chinese and samples that will be used in experiments according to the outline for compiling the application file.
5) Examine whether the original document is good, guide the client to supply materials till the final Chinese version is accomplished.
6) Compile the English version of the application file.
7) According to the COS' requirements and the speciality of our client, we will design a plan of experiments and then complete the experimentation.
8) Examine the final application file's quality with European experts and write a report of the application file's evaluation.
9) Formally submit the application.
10) Keep contact with EDQM, advance the process of registration.
11) Respond to EDQM's questions.
12) Acquirement of COS.
The mode of our COS registration service:
We are willing to establish a close relationship between the client and us, to offer special consulting service according the actual situation and our client's special requirements. At the same time, thanks to our advanced project management, every project has its own manager, who is in charge of the client relationship and the internal coordination, so as to serve clients rapidly and effectively.
1) Agent for COS registration: the client totally entrust the COS registration to us, he just needs to give us the original Chinese documents. We will accomplish the application file, take experiments, and examine documents, contact people, etc., till we get the COS finally. This mode is propitious to control the progress of project, and to ensure that the client can get the COS in the shortest period.
2) Consulting service of COS registration: according to the client's request, we can provide consulting service by stages; provide the outline for compiling the application file and staff training; take experiments or guide the client to take experiments; compile the application file; provide the expert's report; submit the application and keep in contact with the committee of examination, etc. |
