| 579 |
FDA: Data Integrity and Compliance with Drug CGMP, Q&A 확정 발표 |
2018-12-20 |
| 578 |
Canada GMP 및 Annex의 2018년 개정판 발효 |
2018-11-10 |
| 577 |
EDQM: "How to read CEP" 발행 |
2018-08-28 |
| 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 |
