| 日期 | PIC/S GMP系列 | |
| 202409 | PICS Annex 20 (Appendix II Potential Applications for QRM) <More...> | |
| 202408 | PICS Annex 20 Appendix I Risk Management Methods and Tools <More...> | |
| 202407 | PICS Annex 20 QRM <More...> | |
| 202306 | PIC/S GMP Annex 1 Manufacture of Sterile Medicinal Products <More...> | |
| 202301 | PIC/S GMP (PI 053-1) Q&A of HBEL (Jun2020) <More...> | |
| 202212 | PIC/S GMP (PI 043-1) Cross-contamination in Shared Facilities (Jul2018) <More...> | |
| 202210 | PIC/S GMP (PI 046-1) Guideline on Setting HBELs for Use in Risk Identification in The Manufacture of Different Medicinal Products in Shared Facilities (Jul2018) <More...> | |
| 202209 | PIC/S GMP (PE 009-16) Annex 2B Manufacturer of Biological Medicinal Substances and Products for Human Use <More...> | |
| 202208 | PIC/S GMP (PE 009-16) Annex 2A Manufacturer of Advanced Therapy Medicinal Products for Human Use <More...> | |
| 202207 | PIC/S GMP (PI 045-1) Guidelines on The Formalised Risk Assessment for Ascertaining The Appropriate GMP for Excipient of Medicinal Products for Human Use (Jul2018) <More...> | |
| 202206 | PIC/S GMP (PE 009-16) Annex 16 Certification by The AP and Batch Release <More...> | |
| 202205 | PIC/S GMP (PE 009-16) Annex 13 Manufacture of Investigational Medicinal Products <More...> | |
| 日期 | EU GMP系列 | |
| 202410 | FAQs OF EU GMP Annex 1 (2022) Rev. 1 <More...> | |
| 202406 | OOS Investigations (MHRA) <More...> | |
| 202403 | On the preparation of a EU SMF <More...> | |
| 202311 | EMA Q&A on risk based prevention of cross contamination <More...> | |
| 202310 | EU Annex 16 Certification by a QP and Batch Release <More...> | |
| 202309 | EMA FAQs of GMDP <More...> | |
| 202304 | ECA Guideline How to Develop and Document a Contamination Control Strategy <More...> | |
| 202303 | Guidance Template QP Declaration concerning GMP (May2014) <More...> | |
| 202302 | Reflection paper on EU GMP and MA Holders <More...> | |
| 202209 | EU Annex 1 Manufacture of Sterile Medicinal Products <More...> | |
| 202208 | EU Annex 21 Importation of Medicinal Products <More...> | |
| 日期 | cGMP系列 | |
| 202401 | Contract Manufacturing Arrangements for Drugs Quality Agreements <More...> | |
| 202308 | Investigation OOS Test Results for Pharmaceutical Production <More...> | |
| 202211 | Non-Penicillin-Beta-Lactam-Drugs--A-CGMP-Framework-for-Preventing-Cross-Contamination <More...> | |
| 日期 | ICH系列 | |
| 202307 | ICH Q9 (R1) QRM <More...> | |
| 202305 | ICH Q8 (R2) Pharmaceutical Development <More...> | |
| 日期 | WHO系列 | |
| 202312 | WHO GMPs for excipients used for pharmaceutical products <More...> | |
| 日期 | PDA系列 | |
| 202402 | Reducing Human Error for Manual Visual Inspection <More...> | |
| 日期 | ASTM系列 | |
| 202405 | ASTME3263-20 Introduction To ASTM E3263-20 <More...> | |
| 202404 | ASTM E3219-20 Standard Guide for Derivation of HBELs <More...> | |
| 日期 | APIC系列 | |
| 202411 | APIC Quality Agreement guideline Template (final version Jan 2024) <More...> | |