New Draft Guidances on Pharmacopeial Tests for Parenterals

January 9, 2008
BioPharm International Editors

The US Food and Drug Administration has published for public review and comment two annexes to the International Conference on Harmonization’s (ICH) Q4B guideline, Evaluation of Pharmacopeial Texts for Use in the ICH Regions.

The US Food and Drug Administration has published for public review and comment two annexes to the International Conference on Harmonization’s (ICH) Q4B guideline, Evaluation of Pharmacopeial Texts for Use in the ICH Regions. The FDA published the drafts in the Federal Register on December 17, 2007.

Annex 2, Test for Extractable Volume of Parenteral Preparations General Chapter, states that the three official pharmacopeial texts on extractable volume from the European, Japanese, and US Pharmacopeias can be used interchangeably in the three ICH regions. In implementing this annex, the US FDA reserves the right to “request that a company demonstrate that the chosen method is acceptable and suitable for a specific material or product, irrespective of the origin of the method.”

Annex 3, Test for Particulate Contamination: Subvisible Particles General Chapter, allows the three official pharmacopeial texts on particulate contamination be used interchangeably, provided that instrument calibration and system suitability measurements follow regional good manufacturing practices requirements.

Annex 3 also notes that the acceptance criteria are not interchangeable at the100-mL nominal volume, for which the Japanese criteria are more stringent.

Comments on the documents may be submitted until February 15, 2008.

Complete text of Annex 2

Complete text of Annex 3