EC revises stability testing
In the draft guidance the European Commission (EC) expands on its 2005 document with the addition of more scenarios of major, Type II, variations, such as a change to finished product batch size.
Data that must be submitted to accompany a number of Type II changes is detailed in the draft guidance. For example, if a change in batch size alters ingredient quality characteristics, such as impurity, comparative stability data in accelerated and long-term testing needs submitting.
A change to batch size is one of a number of new scenarios discussed in the guidance. In the earlier version three Type II variations were detailed, whereas the new document lists nine. Despite the increase the EC notes that data that needs to be submitted is undefined for the majority of cases.
The EC has expanded information on what to do when switching immediate packaging to cover active pharmaceutical ingredient (APIs) and finished products. Procedures for finished products are unchanged but are now accompanied by details of what to do with sterile APIs.
“Comparative stability data are required using accelerated and long term testing conditions of six months duration on at least two pilot scale batches of the active substance”, the guidance reads.
In the draft guidance the EC outlines the procedure when switching to an ingredient supplier that uses “a substantially different route of synthesis or manufacturing conditions”. The approach taken depends on a number of factors, such as the stability of the API.
For unstable APIs the EC asks for six month data on three batches produced at a minimum of pilot scale. In contrast, stable APIs need three month data from just one batch manufactured at pilot scale or bigger.
Comments can be sent until January 31 2012.