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www.fdanews.com/articles/158800-asean-document-draws-on-fda-ich-process-validation-guidelines

ASEAN Document Draws on FDA, ICH Process Validation Guidelines

September 20, 2013
The Association of Southeast Asian Nations recently released draft guidance that updates process validation processes using a quality-by-design approach. The ASEAN guideline includes recommendations from the U.S. FDA and the International Council on Harmonisation.
International Pharmaceutical Regulatory Monitor