[Stability Testing related News – vol.7]

◆　ASEAN Countries publish Draft of a Guideline on Process Validation（04-Sep-13　ECA）

The member states of the Southeast Asian association (ASEAN) have released the draft of a process validation guideline under the management of Singapore. The guideline is entitled “Guidance for Quality by Design as an alternative Approach to Process Validation”. The document is composed of 10 pages and is very much in line with FDA’s guideline on process validation from 2011.

◆　Quality by Design: Lessons learnt from EMA/FDA Pilot Program（03-Sep- 13　ECA）

In March 2011, the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) launched a joined pilot program on Quality by Design (QbD) applications. As a result of this pilot program, the EMA and FDA reached agreements on a wide range of QbD aspects, which are summarised in a Q&A section in the report.

◆　Authorisation of Generic Drugs in the USA: Requirements on APIs Stability Data for US Drug Master Files（19-Sep-13　ECA）

According to the new Generic Drug User Fee Act (GDUFA) for the marketing authorisation of generic drugs in the USA, the Drug Master File (TypeII) for APIs must undergo a completeness assessment. The statements laid down in the Q&A document regarding the stability data of the API required in a DMF are explicit: in addition to the stability protocol and commitments, data demonstrating the beginning of stability studies have to be provided. The initial and one additional time point for the accelerated studies and long-term studies are sufficient. Yet, the DMF holder should provide amending data to keep the DMF as up-to-date as possible. This is the only way to ensure the successful completeness assessment by the reviewer in the Office of Generic Drugs (OGD) of the FDA.