Question: GMP 에서 socks 는 어떻게 관리하도록 명시되어 있나요?
QbD Answer:
In the context of Good Manufacturing Practice (GMP) guidelines, the management of socks is specifically addressed to minimize contamination risks in cleanroom environments. According to the documentation outlined in PE 009-17 (Annex 1), dated 22-25 August 2023, socks are part of the gowning requirements for personnel entering certain cleanroom grades, particularly grades B and C (Unknown2022g page 30snap).
Before entering change rooms leading directly to grade B and C areas, personnel are required to wear facility socks that cover the feet. These facility socks, along with single or two-piece trouser suits, must be worn to ensure that outdoor clothing, except for personal underwear, is not brought into these change rooms. This practice is crucial to prevent any risk of contamination to the gowning area or the processes within the cleanroom (Unknown2022g page 30a).
The guidelines emphasize that facility suits and socks should not present a risk of contamination. This is part of a broader protocol to maintain gown cleanliness and ensure that the cleanroom environment remains uncontaminated. The management of socks, as part of the gowning process, is integral to maintaining the sterility and cleanliness required in the manufacture of sterile medicinal products (Unknown2022g page 30snap).
Overall, the GMP guidelines highlight the importance of appropriate gowning, including the use of facility socks, to minimize the shedding of fibers and particles, thereby reducing the risk of contamination in cleanroom environments (Unknown2022g page 30a).
AI Answer:
In Good Manufacturing Practice (GMP) guidelines, socks are typically managed as part of the gowning requirements to ensure cleanliness and prevent contamination in controlled environments. Personnel entering cleanrooms are often required to wear facility-provided socks that are specifically designed to minimize the shedding of fibers and particles. These socks are usually worn in conjunction with other protective garments, such as gowns and overshoes, to maintain the sterility of the environment. The use of facility socks helps to prevent the introduction of contaminants from outdoor clothing and is a critical component of the overall gowning protocol in GMP-regulated facilities.
References
(Unknown2022g page 30a): Unknown, 83_2022_PICS_2022 PIC_S REVISED ANNEX 1 MANUFACTURE OF STERILE MEDICINAL PRODUCTS_ TO GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS, 2024
(Unknown2022g page 30snap): Unknown, 83_2022_PICS_2022 PIC_S REVISED ANNEX 1 MANUFACTURE OF STERILE MEDICINAL PRODUCTS_ TO GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS, 2024
Question: GMP 에서 socks 는 어떻게 관리하도록 명시되어 있나요?
QbD Answer:
In the context of Good Manufacturing Practice (GMP) guidelines, the management of socks is specifically addressed to minimize contamination risks in cleanroom environments. According to the documentation outlined in PE 009-17 (Annex 1), dated 22-25 August 2023, socks are part of the gowning requirements for personnel entering certain cleanroom grades, particularly grades B and C (Unknown2022g page 30snap).
Before entering change rooms leading directly to grade B and C areas, personnel are required to wear facility socks that cover the feet. These facility socks, along with single or two-piece trouser suits, must be worn to ensure that outdoor clothing, except for personal underwear, is not brought into these change rooms. This practice is crucial to prevent any risk of contamination to the gowning area or the processes within the cleanroom (Unknown2022g page 30a).
The guidelines emphasize that facility suits and socks should not present a risk of contamination. This is part of a broader protocol to maintain gown cleanliness and ensure that the cleanroom environment remains uncontaminated. The management of socks, as part of the gowning process, is integral to maintaining the sterility and cleanliness required in the manufacture of sterile medicinal products (Unknown2022g page 30snap).
Overall, the GMP guidelines highlight the importance of appropriate gowning, including the use of facility socks, to minimize the shedding of fibers and particles, thereby reducing the risk of contamination in cleanroom environments (Unknown2022g page 30a).
AI Answer:
In Good Manufacturing Practice (GMP) guidelines, socks are typically managed as part of the gowning requirements to ensure cleanliness and prevent contamination in controlled environments. Personnel entering cleanrooms are often required to wear facility-provided socks that are specifically designed to minimize the shedding of fibers and particles. These socks are usually worn in conjunction with other protective garments, such as gowns and overshoes, to maintain the sterility of the environment. The use of facility socks helps to prevent the introduction of contaminants from outdoor clothing and is a critical component of the overall gowning protocol in GMP-regulated facilities.
References
(Unknown2022g page 30a): Unknown, 83_2022_PICS_2022 PIC_S REVISED ANNEX 1 MANUFACTURE OF STERILE MEDICINAL PRODUCTS_ TO GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS, 2024
(Unknown2022g page 30snap): Unknown, 83_2022_PICS_2022 PIC_S REVISED ANNEX 1 MANUFACTURE OF STERILE MEDICINAL PRODUCTS_ TO GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS, 2024