Industry News

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…