International Conference on Harmonisation (ICH), has issued a guideline on good manufacturing practices for active pharmaceutical ingredients (APIs). This is the updated ICH Q7 guideline in which the ...
The ICH guidance document on Validation of Analytical Procedures, ICH Q2, has been updated to Q2(R2). A new ICH guidance document on Analytical Procedure Development, Q14, has been introduced. The ...
Last week, the U.S. Food and Drug Administration (FDA) issued draft guidance on Good Clinical Practice (GCP), adopting the International Council for Harmonisation’s (ICH) “E6(R3)” guidelines. Below we ...
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