324 |
PDA Letter _PUPSIT and the Annex 1 Revision(2019)(번역) |
2024-11-15 |
323 |
개정된 PDA TR 22 Process Simulation for Aseptically Filled Products 대한 Q&A |
2024-11-11 |
322 |
데이터 완전성(Data Integrity) 가이드라인 외. |
2024-11-04 |
321 |
(ECA) GMP Question and Answer Version 2.0.(2020) |
2024-10-31 |
320 |
(FDA) Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (2022) |
2024-10-31 |
319 |
ECA _ GMP 심사원 Reference Handbook |
2024-10-29 |
318 |
(ECA) Container Closure Integrity testing of medicinal products for parenteral use 2020(원본) 비경구용 의약품의 용기 마개 무결성 테스트 |
2024-10-28 |
317 |
(ECA) New version 4.0 of the ECA Visual Inspection Guide published(비경구의약품의 육안검사) |
2024-10-28 |
316 |
Contamination Control Strategy (CCS) - Version 2.0 of the Guideline from ECA |
2024-09-02 |
315 |
Annex 1 스위스 식약처 Q&A |
2024-08-29 |