Quality and Regulatory
GMP is the life of our company. FSP was CFDA GMP approved back to 2007, and got US-FDA approved in 2015.
We are the only GMP approved factory in China by CFDA of Paclitaxel natural process and semi-synthetic process.
FSP consider GMP as the life of our company
FSP strictly implement the GMP guidelines.
FSP passed international pharmaceutical GMP inspection.

 
Current system for managing quality is performed in accordance with cGMP guidance for drug products, such as ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
Quality Management System is consisted of Quality Assurance Department, Quality Control department and Regulatory Affairs Department. The departments are under supervised by the Quality Director who in charge of the whole system.
The manufacture is performed according to the validated and approved production processes, the operator should be trained periodically, all the production equipment and instrument have been qualified or calibrated before used.
All the related quality activities (manufacturing, validation, qualification, training, deviation, change, OOS/OOT, packaging, labeling, testing, releasing, etc) must been recorded according to the approved procedures. 
Quality Risk Management (QRM)
Risks to quality have been assessed and managed in a variety of informal ways based on, for example, compilation of observation, trends and other information. Such approaches continue to provide useful information that might support topics such as handling of complaints, quality defects, deviations and allocation of resources. 

Quality Assurance (QA)
The Quality Assurance department is involved in all matters relating to quality. 
QA is responsible for training, validation, document review and the approval of batch records and batch release, etc.
Quality Control (QC)
The Quality Control department tests all samples, from incoming raw materials, starting materials, in-process samples and finished product, for compliance against pre-established specifications to ensure that quality is monitored throughout the process. The QC department is also responsible for monitoring the water systems and environmental control for particulate and microbial levels in the facility and equipment. In addition, the QC department manages the stability studies and performs the testing of stability samples in which batches of each product are set up in stability chambers according to the ICH storage conditions. The department is staffed by well-educated and well-trained analytical chemists. The laboratories, including a microbiology laboratory, are equipped with a wide range of fully automated and validated state-of-the-art instruments.
Regulatory Affairs(RA)
RA is responsible for updating regulatory requirement and give strategic and technical advise in right beginning of product R&D , documentation submission to regulatory agencies, customers and carry out all the subsequent negotiations necessary to obtain and maintain marketing authorization for the products concerned.
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