Solutions to pharmaceutical equipment management and maintenance problems


(1) apply “value engineering method” to purchase equipment, the specific procedures are as follows. Clear requirements, determine the choose and buy equipment – target enterprise information (information include: operation policy, management goal, the scale of production and management state, etc.) – the target product were analyzed, the analysis of target products of fine, namely function classification, specific and explicit function, then, analysis of equipment function and the matching degree of the actual demand, considering equipment functional, practical focus sort) – evaluation scheme (through group discussion, consulting experts and other methods analysis on the advantages and disadvantages of the equipment to conduct cost analysis and, then, to integrate the key object, and sorting), determine the target of choose and buy.

(2) installation and acceptance of pharmaceutical equipment. Strictly in accordance with GMP requirements and related operating procedures for pharmaceutical equipment installation and acceptance. Participants include: production, engineering, power, QA and outside experts. The specific process is: installation confirmation, operation confirmation. QA is responsible for inspection and validation of GMP project, audit and verification.

(3) information construction. According to the equipment technical manual and GMP, consult relevant experts, compile the equipment maintenance table and technical manual, and record in detail the previous maintenance data, maintenance methods and maintenance effects, so as to promote the informatization and standardization of pharmaceutical equipment management and maintenance.

(4) implementing the “two sessions” system. As pharmaceutical equipment management is characterized by strong professionalism, complex problems and wide range of fields, as well as the suddenness and concealment of equipment failures, it requires us to establish a fast and efficient operation, response mechanism and timely handling of failures. Shift briefing (refers to the use of 10 min before going to work every day, to summarize and discuss 1 d before work and the work plan of this day) and department weekly meeting (inspection, review performance this week, this week to discuss the main problems, discuss the solution, and setting up a work plan next week), which can effectively enhance work standardization, is of great significance to reduce the security hidden danger.

Post time: Feb-27-2020