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

 

Introduction

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
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