An NSF International Company ASEAN Process Validation Draft Guidance
Friday the 13th September 2013
In September 2013 the member states of the Southeast Asian association (ASEAN) released a 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 the FDA’s 2011 guidance on process validation.
Members of the ASEAN countries are: Thailand, Singapore, Indonesia, Malaysia, Vietnam, the Philippines, Myanmar, Cambodia and Brunei. Thus, the association represents almost 600 million people - around 8% of the world population.
