| Purified water system is the key equipment of pharmaceutical enterprises and the key audit item of "facility and equipment system" in GMP certification standard of pharmaceutical production industry,whose stable and reliable operation is the necessary guarantee of purified water quality.In the context ofguaranteeing the progress and quality of the purified water renovation project,scientific and effective control and management directly affect the quality and overall benefits of pharmaceutical products and have far-reaching significance for pharmaceutical enterprises.In this paper,a set of solutions for purification water system renovation project progress and quality control were present using the progress control and quality management tools on the basis of the process design of purified water system,equipment installation,commissioning,operation,4Q verification,acceptance and other technologies.In terms of project progress control,there is a limit to the resources that can be used within the planned time,and the insufficient allocation of resources will affect the progress of transformation,which requires the use of innovative,detailed and more realistic network plan to arrange the project progress.The key works of the project were determined on the premise of quality standards by using WBS tools to decompose tasks and assign responsibilities.Considering all the constraints,the network plan and project schedule were developed and implemented reasonably.In terms of project quality control,the main contents and factors involved in quality management were analyzed in view of the particularity of purified water project quality management in pharmaceutical enterprises,and the key system quality control and quality improvement solutions were standardized and implemented by combing the quality management process.The projectquality was guaranteed at the stages of design,construction and acceptance through the implementation of the quality responsibility system and the development of standard operating procedures by means of quality management methods such as risk assessment management and verification management.In this paper,the proposed management methodsare applied in the engineering practice of comprehensive purified water preparation workshop renovation projectwith controllable progress and standard quality requirements.A set of management mode for similar purified water reconstruction project is explored by taking the engineering management mode as the background,the GMP standard of pharmaceutical enterprises as the basis,the quality standard as the principle of the project progress management,and the progress plan as the target of the project quality control,which obtains good application results,and provides an effective reference and guidance for the subsequent similar reconstruction and construction. |
