606 |
EMA: Overview of Comments on ICH Q9(R1) 발표 |
2022-05-04 |
605 |
FDA: Microbiological Quality Considerations in Non-sterile Drug Manufacturing(draft) 발표 |
2021-10-08 |
604 |
TiO2: no longer considered safe when used as a food additive |
2021-10-07 |
603 |
FDA: QnA on Quality Related Controlled Correspondence 발행 |
2021-09-29 |
602 |
PIC/S Good practices for data management and integrity in regulated GMP/GDP environments 번역본 |
2021-07-28 |
601 |
PIC/S Document: Evaluate & Demonstrate the Effectiveness of PQS (PI 054-1) |
2021-07-21 |
600 |
GMP Compliance Inspection concerning Drugs and Quasi-drags of Foreign Manufacturers(일본) |
2021-07-05 |
599 |
PIC/S GMP Guide 개정_PE 009-15(20210501) |
2021-06-09 |
598 |
TGA: Guidance on the management of GMP compliance signals발표 |
2021-06-09 |
597 |
Electronic Signatures and Trust Services Guide (updated 18. Aug. 2016) |
2021-06-01 |