1. The FDA representative of our company contacts the 
pharmaceutical enterprise concerned, introduces our GMP
business and signs the letter of intent with our client
at our company.

2. Based on the references and the status of the factory
offered by the manufacturer, the General Manager calls 
in concerned specialists and technologists to evaluate 
whether the factory can be applicable to be access to the
GMP authentication or not. 

1. Our company shall dispatch a group consisting of the 
GMP specialists, pharmaceutists, technologists and FDA 
representative to the factory for an investigation 
inspection at the invitation of the factory. The expenses
caused by this inspection are covered by the factory.

2. The inspection contains workshop, establishment, 
facilities, training, drug product containers and closures,
production processing system, laboratory and file management
relating to finished product, returned or disposed products.
After the inspection, the group makes a decision whether or
not we would edit the DMF for the factory.

3. Sign "A power of Attorney" entrusting the compilation of 
DMF and refer to the DMF registration to our company. 

4. The American and Chinese specialists concerned are responsible
for compiling the DMF according to the GMP requirements issued by
FDA and then translating into English. Finally it is submitted by
the American consulting agency appointed by our company to the 
headquarters of FDA. FDA shall notify our attorney and the 
consulting agency of acquiring a FDA file number after 
administratively approving.

5. The American GMP specialist (attorney) and the domestic GMP 
specialist authorized by our party shall visit the manufactory 
for inspection and point out problems existed in the hardware 
and software management of GMP in factory, make suggestions and
proposals to the factory according to the FDA requirements 
concerned. The manufactory should improve on their suggestions
strictly.

8. Our party is responsible for training the related employees 
of the factory theoretically in accordance with the GMP standards
and operational procedures issued by FDA to achieve the requirement
concerned.

9. The enterprise should give notice to our party after the 
improvement and we dispatch our GMP specialist again to the factory
for a preliminary check-up. Finally we notify our appointing 
consulting agency in US of inviting FDA official to come to the 
factory for inspection accompanied by our attorney. If qualified, 
our appointing consulting agency (attorney) would give a notice 
to the manufacturer first and then FDA shall issue the GMP 
qualification certificate after the FDA official goes back to US.
　
10. If unqualified, the FDA official together with our attorney
shall give the reason why it is not qualified and make suggestions
about the improvement. One year later, FDA official will inspect 
the factory again together with our attorney. If beyond second 
inspection, the additional expenditures will be calculated separately.