Quality Risk Management And Validation In Multi-Collinear Sterile APIs Workshop

For the pharmaceutical companies,the quality of the products is always the most important.With the in-depth implementation of new GMP,and the China Food and Drug Administration(CFDA)joining the International Council for Harmonization of Technical requirements for Pharmaceuticals for Human use(ICH),it brings forward higher quality management requirements to the domestic pharmaceutical companies.The effective quality risk management,as an important component of the quality management system,will help companies to guarantee the quality of the whole life cycle of the product.For the production of sterile drugs,the production of APIs that needs larger equipment and has process that is more complex brought more sterile challenges than that of preparations.While most of the regulations and guidelines are specified for sterile preparations,the appropriate adjustments are often made in the process of directing the production of sterile APIs.In addition,for China’s pharmaceutical companies,the production of a variety of collinear sterile APIs in the same workshop is a more common phenomenon.Especially for the final step of the pharmaceutical refining process,there are more collinear production situation for the same process.Based on quality risk management,this paper tries to discuss how to avoid contamination and cross-contamination in the production process for multi-collinear sterile APIs.This paper starts from the introduction of the establishment of quality risk management system,including the commonly used quality risk tools such as Fishbone and FMEA.Then one multi-collinear sterile APIs workshop was chosen as example to discuss the multi-collinear quality risk using quality risk tools.After the collinear evaluation,the cleaning method was established base on the high-risk process and the equipment in the APIs workshop and the implementation of the cleaning validation was discussed.Since the sterile risk is most important in the APIs process,this paper tries to design the protocol of simulated canning validation.In the end of the paper,I look forward to the future development of collinear production and the related validations.The quality risk management tools and validation protocols in this paper have significant application value in the quality risk management of multi-collinear products in the production of sterile APIs.It is beneficial for Chinese pharmaceutical enterprises to establish a sustainable quality system for sterile APIs.It makes the people safer to use medicine,which will help China’s sterile APIs to better compete with the international pharmaceutical companies.