USP 797 Environmental Monitoring 101 | HVAC Requirements
USP 797 Environmental Monitoring 101 | HVAC Requirements
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Environmental Monitoring in Pharmaceutical Industry 📍Environmental Monitoring Program โดย ภญ.พัชรา คูถิรตระการ Consultant, National Biopharmaceutical Facility (NBF), KMUTT ผลิตภัณฑ์ยาต้องมีความบริสุทธิ์ ไม่มีสิ่งปนเปื้อนจากสารใดๆ ที่ไม่ใช่ส่วนผสมของผลิตภัณฑ์ที่ต้องการ ปัจจุบัน กองยา สำนักงานคณะกรรมการอาหารและยาของประเทศ ได้กำหนดให้ทำการผลิตยาทั้งชนิดรับประทานและยาฉีดภายใต้ห้องสะอาดในเกรดต่างๆ ตามความวิกฤตของงานที่ดำเนินการ คุณภาพที่ดีของผลิตภัณฑ์จะต้องสร้างขึ้นในตัวผลิตภัณฑ์ ไม่ว่าจะเป็นขั้นตอน
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