Regulation News

Date PIC/S GMP Series
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...>

Date EU GMP Series
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...>

Date cGMP Series
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...>

Date ICH Series
202307  ICH Q9 (R1) QRM <More...>
202305  ICH Q8 (R2) Pharmaceutical Development <More...>

Date WHO Series
202312  WHO GMPs for excipients used for pharmaceutical products <More...>

Date PDA Series
202402  Reducing Human Error for Manual Visual Inspection <More...>

Date ASTM Series
202405  ASTME3263-20 Introduction To ASTM E3263-20 <More...>
202404  ASTM E3219-20 Standard Guide for Derivation of HBELs <More...>