There is a huge amount of technology transfer being carried out within the
pharmaceutical industry at present and very little guidance on how to do it effectively.
Therefore, the ISPE in collaboration with the FDA and the American Association of
Pharmaceutical Scientists (AAPS), and with input from the European regulatory
authorities and submission to the Japanese Ministry of Health and Welfare (MHW),
have created a user-friendly document that presents a clear and concise general process
for transferring technology between two parties. The guide has been designed to present
a standardized process and recommends a minimum base of documentation in support
of the transfer request. The guide is divided into three segments: active pharmaceutical
ingredients, dosage forms, and analytical methods.
那位可以搞到这个指南啊!
ISPE Good Practice Guide: Technology Transfer
pharmaceutical industry at present and very little guidance on how to do it effectively.
Therefore, the ISPE in collaboration with the FDA and the American Association of
Pharmaceutical Scientists (AAPS), and with input from the European regulatory
authorities and submission to the Japanese Ministry of Health and Welfare (MHW),
have created a user-friendly document that presents a clear and concise general process
for transferring technology between two parties. The guide has been designed to present
a standardized process and recommends a minimum base of documentation in support
of the transfer request. The guide is divided into three segments: active pharmaceutical
ingredients, dosage forms, and analytical methods.
那位可以搞到这个指南啊!
ISPE Good Practice Guide: Technology Transfer