Technology Transfer: A Contract Manufacturer's Perspective - Meticulous planning and execution are necessary to ensure a seamless transition of processes between partners. - BioPharm International

ADVERTISEMENT

Technology Transfer: A Contract Manufacturer's Perspective
Meticulous planning and execution are necessary to ensure a seamless transition of processes between partners.


BioPharm International


During routine commercial manufacturing, critical parameters are monitored and trended to ensure that the process is still operating in a valid manner. Reprocessing or rework is allowed at this stage if such processes are being validated under protocol or if such processes have already been validated. Reprocessing or rework requires approval of the sponsor.

ConclusionImplementation of this procedure for process development and transfer enables Diosynth and its customers to use a common language to manage expectations for contracted work.

References1 Diosynth Standard Operating Procedure SOP#80GN1327: Evaluation, Development and Execution of Manufacturing Processes at Diosynth RTP


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

GPhA Issues Statement on Generic Drug Costs
November 20, 2014
Amgen Opens Single-Use Manufacturing Plant in Singapore
November 20, 2014
Manufacturing Issues Crucial to Combating Ebola
November 20, 2014
FDA Requests Comments on Generic Drug Submission Criteria
November 20, 2014
USP Joins Chinese Pharmacopoeia Commission for Annual Science Meeting
November 20, 2014
Author Guidelines
Source: BioPharm International,
Click here