25/26 January 2023
The member states of the Southeast Asian association (ASEAN) have released the draft of a process validation guideline under the management of Singapore. Members of the ASEAN countries are: Thailand, Singapore, Indonesia, Malaysia, Vietnam, the Philippines, Myanmar, Cambodia and Brunei. In a word, the association represents almost 600 millions of people - around 8% of the world population.
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. The ICH guidelines ICH Q8, 9, 10 and 11 are much more integrated than in the FDA guideline. This can be seen in the pictures in the draft which are taken from the ICH guidelines and also in the glossary. In addition, many terms from the ICH guidelines in question are used. The document also refers to "Points to consider" documents in relation with ICH Q8-11. The draft explicitly addresses medicinal products (chemical, biological) as well as APIs. Regarding APIs, it is explicitly recommended to have a look at the examples described in the ICH Q11 document. As in FDA's guideline, the draft document combines GMP requirements and marketing authorisation aspects. A specific chapter is available on the topic Common Technical Document (CTD) and describes where some information in the CTD have to be provided. The ASEAN countries have taken over the CTD format as A(sean)CTD.
The title "Guidance for Quality by Design as an alternative Approach to Process Validation" is, however, misleading because, Quality by Design isn't presented as an alternative in the document but as support within validation. Again, this is a clear parallel to the FDA guidance. The "Validation Life Cycle" with 3 steps (Process Design, Process Qualification, Continued Process Verification) have also been taken over as such by the ASEAN countries.
Conclusion: The ASEAN draft doesn't really present something "new" compared to FDA's Process Validation Guidance from 2011. Those who would like to better understand the connection of the ICH Q8-11 guidelines with modern process validation should consult the draft.
More information can also be found in the draft "GUIDANCE FOR QUALITY BY DESIGN AS AN ALTERNATIVE APPROACH TO PROCESS VALIDATION".
PS: Because of high demand for the topic "modern process validation", the ECA has just organised an additional course "The new FDA/EU Approach to Process Validation" which will take place on 14/15 October 2013 in Barcelona, Spain. Please note that the course is limited to 35 participants!