Industry News

ICH has published a Revised Guideline on Quality Risk Management Q9(R1) on 18 January 2023. GMP Consultants can provide you with a word by word comparison of the 2005 vs 2023 documents. If you would like to purchase a copy…

FDA has published a revised version of the Guidance on “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production“ on 16 May 2022. GMP Consultants can provide you with a word by word comparison of the 2006 vs 2022 documents. If…

ICH has published a Draft Guideline on Analytical Procedure Development Q14 on 24 March 2022.

ICH has published a Draft Revised Guideline on Validation of Analytical Procedures Q2(R2) on 24 March 2022. The document is a complete revision of guideline to include more recent application of analytical procedures and to align content with Q14.

Health Canada has published a revised version of “Good Manufacturing Practices Guidelines for Active Pharmaceutical Ingredients” (GUI-0104) on 10 February 2022. GMP Consultants can provide you with a word by word comparison of the 2013 vs 2022 documents. If you…