The requirements for production management and quality management in the "Good Manufacturing Practice for Drugs" aim to minimize the risks of contamination, cross contamination, confusion, errors, etc. in the drug production process. Personnel are the most important element in implementing various operations, and they are also the control difficulty in preventing cross contamination. Effective protection of personnel can effectively avoid cross contamination. Clean clothing provides important protection for personnel, and the management, selection, and use of clean clothing have become crucial.

according toArticle 34 of the 2010 version of GMP stipulates that any personnel entering the production area shall change clothes in accordance with the regulations. The selection, style, and wearing method of work clothes should be suitable for the job and air cleanliness level requirements.

In the appendixArticle 24 of Sterile Drugs stipulates that workwear and its quality should be suitable for the requirements of production operations and the cleanliness level of the operating area. Its style and wearing method should meet the requirements for protecting products and personnel. Among them, forA/B levelRegulations on Dress Code for Clean AreasAll hair and beard related parts should be covered with a hood, which should be tucked into the collar. A mask should be worn to prevent the emission of droplets, and protective goggles should be worn if necessary. Rubber or plastic gloves that have been sterilized and free of particulate matter (such as talcum powder) should be worn, and foot covers that have been sterilized or disinfected should be worn. The pant legs should be tucked into the foot covers, and the cuffs should be tucked into the gloves. Work clothes should beCleanroomA specialized sterilization jumpsuit that does not shed fibers or particles and can retain particles emitted from the body.

Grade CRegulations on Dress Code for Clean AreasHair, beard and other related parts should be covered, and a mask should be worn. Wear a jumpsuit that can be tightened at the wrist or a work uniform with separate clothes, and wear appropriate shoes or shoe covers. Work clothes should not shed fibers or particles.

Grade DRegulations on Dress Code for Clean AreasHair, beard and other related parts should be covered. Suitable work clothes and shoes or shoe covers should be worn. Appropriate measures should be taken to avoid introducing pollutants outside the clean area.

In addition, personal clothing is not allowed to be brought into the entranceChanging rooms in B/C level areas. Each employee should change into sterile work clothes every time they enter the A/B level area. During operation, gloves should be disinfected regularly and masks and gloves should be replaced if necessary.