Xiaoyi will introduce you to GMP standard and GMP workshop.
GMP standard is a set of mandatory standards applicable to pharmaceutical, food and other industries. It requires purifying engineering enterprises to meet the requirements of hygienic quality in terms of raw materials, personnel, facilities and equipment, production process, packaging and transportation, quality control and other aspects in accordance with relevant national regulations, and to form a set of operational norms to help enterprises improve enterprise hygiene. Environment, timely detection of problems in the production process, to improve. Briefly speaking, GMP requires enterprises to have good production equipment, reasonable production process, perfect quality management and strict inspection system to ensure that the quality of final products meets the requirements of regulations.
In GMP workshop, the wall and roof of purification workshop are usually made of 50 mm thick sandwich color steel plate, which is characterized by beautiful appearance and strong rigidity. Arc corner, doors, window frames, etc. are generally made of special alumina profiles.
In order to prevent cross-contamination in GMP workshop, tools for cleaning and purifying workshop facilities should be specially designed according to product characteristics, process requirements and air cleanliness level, and garbage should be put into dustproof bags and taken out.
Cleaning in GMP workshop must be carried out before commuting and after the end of production process operation; cleaning should be carried out in the operation of air conditioning system in purification workshop; after cleaning, the air conditioning system should continue to operate until the specified clean level is restored, and the start-up time is generally not shorter than the self-cleaning time of GMP workshop. The disinfectants used should be replaced regularly to prevent microorganisms from developing resistance. When large items are moved into the workshop, they should be cleaned by vacuum cleaner in general environment first, and then allowed to enter the purification workshop. They should be further treated by vacuum cleaner or wiping method in the clean room. During the stop of operation of the purification system in GMP workshop, large items are not allowed to be moved into the purification workshop.
GMP purification workshop to carry out disinfection and sterilization, can use dry heat sterilization, wet heat sterilization, radiation sterilization, gas sterilization, disinfectant disinfection.