576 |
FDA: Guidance on Elemental Impurities in Drug Products 발표 |
2018-08-28 |
575 |
식약처: 2018 자주하는 질문집 |
2018-08-14 |
574 |
FDA: Guidance for Industry - Bioanalytical Method Validation 발표 |
2018-07-18 |
573 |
EU GMP Guide Annex 17 RTRT and Parametric Release 발표 |
2018-07-18 |
572 |
Highly Purified Water(HPW): 유럽 약전에서 삭제 |
2018-07-11 |
571 |
APIC: Guide for auditing registered Starting Materials manufacturers 발표 |
2018-04-18 |
570 |
MHRA: GXP Data Integrity Guidance and Definitions Revision 1, March 2018 |
2018-03-13 |
569 |
Health Canada: Risk classification guide for drug good manufacturing practices observations |
2018-03-05 |
568 |
식약처: “우수화장품 제조 및 품질관리기준(CGMP)해설서(민원인 안내서)” 발행 |
2018-02-15 |
567 |
식약처: 「의약품 등의 안전에 관한 규칙」개정안 입법예고 |
2018-02-01 |