Understand ICH Q7 S11

What is expected in terms of impurities for APIs extracted from herbal or animal tissue origin [ICH Q7, 11.2]?

In cases where the API itself is the extract from an herbal or animal tissue preparation, all constituents of this extract (concomitant constituents) might be considered to be part of the API. Therefore, a production process-related impurity profile (except, for example, solvents used in the process), would generally not be expected. However, for all APIs derived from herbal or animal sources, tests and limits for possible contaminants originating from these sources (e.g., pesticides, mycotoxins, viruses, herbicides, elemental impurities and wrong species) should be established, based on a risk assessment. In cases where herbal or animal sources provide material that is further processed to yield a chemically-defined API, all constituents other than the API are considered impurities. In this situation, the API manufacturer would be expected to establish an impurity profile as well as an API release specification that would include impurity limits. In any case, it is the API manufacturer’s responsibility to establish batch release specifications for APIs to ensure that they are safe and of high quality, consistent with appropriate regulatory requirements, applicable compendial specifications and regional expectations [ICH Q7, 11.21;  ICH Q9; ICH Q11

In cases where an API test method is changed, which method should be used for stability studies already in progress?

The company should decide and justify the decision of which method to use. All test methods for stability studies [ICH Q1A] should be validated and demonstrated to be stability indicating prior to use [ICH Q7, 11.51]. Any changes to stability test methods should be documented. Applicability of the changes to the existing stability studies should be assessed and may require filing in accordance with regional requirements for post-approval changes [ICH Q7, 13.11].