Pharmaceutical Equipment Management Method

The excellent GMP accordance and technique condition of pharmaceutical equipment is critical technique base to ensure medicine quality. Stale concepts of equipment administration, outdate equipment administration methods, Equipment administration validate, only are formality etc. except for quality administration problems and immature technology. There are many risks of drug quality. Which caused accidents related to drugs in society and those unqualified drugs threaten our health and medicine usage safe.Based on my theory study of GMP guildline and equipment administration, and combine my many years equipment administration experience to raise the detail measures to improve equipment administration.1. Establish an equipment administration model that accordance to the requirement of quality control of drug production: according the technique character and GMP standard of the equipment, norm the regulatly maintain of machine, conservation and check; revising the instruction of the position, maintain and reserve the equipment and carry out the responsibility system; carry out achievement management, establish achievement plan that accordance to requirement of equipment administration , to stimulate the staff to improve work achievement through achievement control, achievement check and achievement feedback and improve; establish "two meeting", "two check" regulation, insure the implement of all the regulations and rules, to achieve the equipment administration objective.2. Establish validation committee to responsible for leadership and organization: Validation committee establish whole validation plan according to the request of GMP and the production plan of company, identify the goal and standard of equipment validation, identify the organization framework and responsibility, establish the progress plan of validation, through implement project management to ensure the quality and progress of the equipment validation ,and make sure that the equipment validation do warrantee the quality of the product.3. In order to establish an effective and simple engineer group: optimize the organization framework, improve the operation effective of the organization, carry out optimized combination of talent man, take measures of introducing of talent man and intelligence, optimize the special structure of the staff, establish an effective management group.With the application of the above Methods of pharmaceutical equipment management, the effective utility of the equipment has been improved, equipment validation plan has bee effective carried out, the poor quality of the drug and complain of clients have decrease obviously, and bring great economic and social benefit for the enterprise.