The new document – which can be downloaded here – is part of an effort by the Association of Southeast Asian Nations (ASEAN) to provide manufacturers with a process validation framework for manufacturers of both finished drugs and APIs.
The US Food and Drug Administration’s (FDA) 2011 guideline is clearly an inspiration, although in the ASEAN draft the importance of International Conference on Harmonisation (ICH) Q8 to Q11 are discussed in greater depth.
Another thing that stands out is the title “Guidance for quality by design (QbD) as an alternative approach to process validation.”
However, on closer inspection it is clear that QbD is discussed as a part of process validation rather than as an alternative, which is something we put to David Woo, deputy director of the therapeutic products branch of the Singapore Health Sciences Authority.
“All member states within ASEAN are working on the draft, including the title of the document, to provide guidance for the manufacturers within ASEAN who intend on adopting such an approach [QbD] to manage the life cycle of their products,” Woo told in-Pharmatechnologist.com.
He stressed that the document is still in the consultation phase and “the contents within the draft will likely change as discussions are on-going” adding that it was posted on the HSA site to give Singapore’s local pharmaceutical industry the chance to submit comments.
“It also gives the industry the opportunity to review the document and submit comments through their respective pharmaceutical industry representatives that participate in the technical discussions held at the ASEAN ACCSQ (ASEAN Consultative Committee on Standards and Quality)-PPWG (Pharmaceutical Product Working Group) meetings.”
When discussions are completed and the document is finalised the guidelines are likely to be adopted by all 10 ASEAN members, which are Indonesia, Malaysia, the Philippines, Singapore and Thailand, Brunei, Myanmar, Cambodia, Laos, and Vietnam.