During July 4th to July 7th, 2014, the inspectors of CFDA Drug Inspection Centre FAN Xiaona, ZHANG Xiaosong, WANG wei and the observer of Shanghai FDA went to CNBG Shanghai Institute for the first stage of “Three in One” inspection for Human Rebies Immunoglobulin, and the “Three in One” inspection includes register site inspection of drugs, process qualification and GMP site inspection.
At the first meeting, inspection group leader FAN xiaona pointed that Shanghai institute is the forth pharmaceutical manufacture supplier for “Three in One” inspection and also the first biological products manufacture for the inspection in nationwide after the No.224 documents issued by Drug & Cosmetics Supervision Division of CFDA in 2013. Biological products is one of high risk products so that inspection group focuses on following aspects: the authenticity and feasibility of production process, the consistency with declaration process and the compliance with GMP in 2010 edition.
Shanghai institute attached great importance to this inspection. With moving forward to the construction progress of FENGXIAN site, Shanghai institute made a great deal of preparations for the inspection, which included the preparation of application documents, the arrangement of plasma production, the maintenance of equipments and the training for staff. They also communicated personally many times with experts in Beijing in order to pass the inspection successfully.
The inspection group made their rounds carefully during four days. They checked site of blood derivatives, water-treatment system, air- conditioning system, material warehouse, QA lab and plasma management centre. Due to time constrains, the inspection group went to work immediately after site inspection, and they examined all documents including of training information, batch record, record of equipments maintenance, QC record, information of supplier qualification, deviation record, process validation, clearance validation and so on. Thus they can have a fully understanding in company’s management and operations by integrating site inspection and documents examination. Meanwhile, all staff showed the truest situation of company. Shanghai institute arranged some business backbone to answer the questions from inspection group as well.
Inspection group read out the result of GMP inspection that Shanghai institute passed the GMP inspection. Inspector understood that this GMP inspection was really a difficult and high-risk task for Shanghai institute and they also reaffirmed that there were so many staff with high qualification, excellent communication ability and good teamwork spirit in Shanghai institute. The general manager YAN Zihou expressed that we realized the self-development system inadequate through this inspection so that we could draw inferences about other cases from one instance at the same time of correcting and we wanted to improve our management by practical activities.
R&D department and QA department of Shanghai institute worked together to lead the preparation of GMP inspection. The two departments reach a consensus gradually and enhanced mutual understanding so that they could strengthen the collaboration in work. It’s a good result of implantation the concept of “Quality by Design”, and it is also the victory for carrying out the strategy of “quality leadership and technology innovation”. The successful experience will provide good guidance to the potential products for GMP inspection in on-going construction FENGXIAN site.(CNBG Shanghai Company Submits)