Wednesday, 11 June 2014

Requirements for Process Validation of Biotech Active Pharmaceutical Ingredients (APIs)


Process validation of Active Pharmaceuti-
cal Ingredients (APIs) is still one of the
most challenging topics for both pharma-
ceutical industry and regulatory authorities. It
is the clear expectation of regulatory authori-
ties, especially the FDA and EMEA, that pro-
duction processes, cleaning procedures, ana-
lytical methods, computer and utility systems
that have an impact on product quality and
purity are validated. Facilities and equipment
used in conjunction with production and testing
of APIs must be qualified. T