Studies On Implementation Of GMP Alteration To Ointment Preparation Workshop

The technology arrangement of former ointment workshop of CixiPharmaceutical Co. Ltd was not quite reasonable with small production ground,outdated equipment, and was lack of effective anti-contaminated andanti-cross-contaminated measures. The file system still has a long distance to therequirement of GMP. To get GMP certificate, this work would process amendment toGMP file system from the adjustment of the technology arrangement and lustration ofointment workshop, cleaning air-conditioner, and the alteration to facilities andequipments, and process validation to each system, and explore the effective GMPalteration method to old workshop. The main contents include:The existing problems are analyzed in the technology arrangement andequipments of the former ointment workshop. The alteration scheme is raised and thenecessary workshop area is enlarged. The ointment of hormone kind andnon-hormone kind are both produced in the same workshops. Hence, the relevantconfection equipments are added to the system. Because it is till using the same aircleaning system, the direct-discharge measures to circling wind of hormone quantifyroom, ointment confection room, and filling and sealing room are taken so as toprevent cross-infection. Being processed alteration, the technology arrangement andthe people and material circulation have become reasonable;there are no dead anglesthat are hard to clean in the production area of pipelines, equipments and otherapparatus;and the pipeline connection is correct.It processes amendment to files again and divides the files into four kinds ofstandard management regulations, standard operation program, standard techniqueregulation and record. According to file types and the departments it affiliated with, itprocesses reasonable coding to files, which is convenient for searching. Conformingthe actual equipments condition after alteration, it adds relevant files. Afteramendment, the files become systematic, applicable, dynamic, strict and traceable,which guarantee the regulations of production, by training of staff, reduce thepossibility of the artificial mistake , process under control and the quality of themedicine produce.It processes validation to the rinse of the facilities, main equipments andapparatus in the ointment workshop. Through the validation to ointment workshop, itvalidates that the system could steadily run and guarantee all the indexes eligiblewhen the air cleaning system is manipulating under regulated range. Through thevalidation to each direct discharge cleaning room and other associated rooms after theproduction of hormone ointment, it proves there won't be cross-infection to theproduction of non-hormone ointment. After the validation to the sterilization anddisinfections effect of ozone, it proves that the disinfections to aluminium tube byozone are eligible and it has no influence to the quality of the aluminium tube, in acertain period. Through the validation to the production technique of the ointment, itproves the reliability and steadiness of the production technique and validates that theestablished management regulations, operation program and technique regulationscould meet the requirement of eligible quality and product equality. All the abovevalidations confirm both files and equipments of ointment product are eligible andcan guarantee the production quality of the ointment.Through above work, the company has got GMP certificate and achieved goodeconomy benefits.