Conference on Harmonization Options

The ICH document (1) offers users a choice of any of five different options. Table 1 is a listing of these options. These options arose from the results of a Japanese Pharmaceutical industry survey (2). No effort was made to determine which procedure was best. These results were presented to the QIB Expert Working Group (EWG). The ICH EWG accepted what the Japanese had done and, after debate, adopted it as their guideline. 

The exact goal of the QIB EWG is unclear based on the comments reported by the Rapporteur for the group Beaumont (3). They decided earlier on not to seek the advice of outside experts in this field to aid in the development of this guideline and this shortcoming is evident in their decision-making. 

Further evidence of this lack of expert input is found in the opening line of Option 1, Any light source that is designed to produce an output similar to the D,yiD emission standard. Such a standard does not exist. D, is a Commission Internationale de L Eclairage (CIE) (4) standard and (5) an International Organization for Standardization (ISO) standard. The SPDs of these two standards are different one is a filtered version of the other. 

The ICH needs to decide just which of these standards it is going to recommend, or IDgj. Logic would dictate the former, Eventually, all substances 

Option Description Lamp type Additional requirements 

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