Change Management Based On Safety Risk During Manufacturing Process Of Pharmaceuticals

There exist many risks in the manufacturing process of pharmaceuticals, such as fire, explosion, poisoning, suffocation, mechanical injury, chemical burns, and environmental pollution. Especially, the changes during the manufacturing process often bring the new safety risk. I have engaged in safety production of pharmaceuticals for10years. I analyzed the accidents of pharmaceutical industry over the years and found the occurrence of many extremely large accidents directly relates to inadequate management and control of change process. However, the USA, Europe, Japan, etc have reached and practiced the change management during the manufacturing process at least20years earlier than our country. The safety management during the manufacturing process, especially change management is still in its early stage. State Administration of Work Safety issued Ten Provisions on Maintaining the Work Safety of Chemical (Hazardous Chemicals) Enterprise(Decree No.64of State Administration of Work Safety) in June of2014, based on analysis and summarization of recent years of extremely large accidents of hazardous chemicals industry. The provisions first put forward that the enterprise should strictly manage the change, which is also the request proposed for change management in regulatory level in our country. Therefore, how to guide the enterprise to establish the change management system plays a very important role and significance in the aspects of avoiding the occurrence of extremely large accidents and of safeguarding the employees’ lives and properties. Especially, the manufacturing process of API uses large quantity of organic solvents, and involves many dangerous process steps. Strengthening the safety risk management of the manufacturing process of API plays a fundamental security role in process improvement, energy saving and consumption reducing and R&D of new product.The change management system in this paper is an important management element of process safety management system, and it closely integrates with other management elements. If an enterprise does not carry out the process information management, employee’s training; draft of operation procedure, emergency management, mechanical integrity management, supplier management, etc, change management can not be carried out. Consequently, change management, as an important part of process safety management system, correlates with other elements.This paper describes the design of change system of process safety management system in pharmaceutical enterprise, compilation of change document, running, supervision, improvement of change system, risks introduced by the common changes in pharmaceutical enterprise in details, considering the development characteristics of change management of our country, and learning from the experiences and lessons of European and American international pharmaceutical enterprise. The establishment and running of the change system need recognition and support of the high level of the company, because the implementation of the change system needs to consume some certain resources. Certainly, it can also bring some certain safety performance. The purpose of establishing the change management system by the enterprise is to control the occurrence of rather large accidents. The running efficiency and performance of the change system are the important parameters in evaluating the design quality and running quality of the change system.The change management system needs to review and know the problems existing in the change management system, and to solve the problems, and thus make the change management system improved continuously, and meet the needs of enterprise for development. This paper establishes a set of scientific evaluation methods aiming at running of the change management system, and the enterprise can learn from it.The safety risk introduced by the enterprise’s change is described is Appendix J. The enterprise can organize the professional persons and operators to participate the analysis of safety risk in the change. The enterprise can choose the appropriate safety risk system analysis method based on the type of the change, which is very beneficial to analysis of safety risk in the change.This purpose of this paper is to guide and help the chemicals enterprise, especially pharmaceutical enterprise (to) establish and run the change system which meets their needs. This topic belongs to the initial specific topic; especially the safety risk analysis in the change of pharmaceutical industry is the first study at home. I hope it can promote the development of the safety management of chemical industry.