Chapter 1 - Process Validation: Design and Planning

Abstract

The validation of the aseptic process is particularly challenging. What are the principles and methods for planning and designing the validation of sterile parenteral solution manufacturing operations? Parenteral product manufacturing may include active ingredients, intermediaries, powders, ointments, gels, semisolids, lyophilized, and combination products. This chapter will focus on the validation, capability, and control of sterile liquid drug product manufacturing processes. Sterile liquid parenteral products may be manufactured using aseptic processing, terminal sterilization, or a combination. Many of the principles and approaches discussed with regard to aseptic processing are applicable to terminal sterilization. Aseptic process simulation or media fills might be a tool for proving confidence that the aseptic process was designed and performed properly. However, there are more effective ways to provide confidence that aseptic practices are in place. Confidence in the aseptic practice components of the aseptic process may be better gained through high-efficiency particulate air (HEPA) efficiency testing, velocimeter readings, smoke studies, design review, disinfection efficacy studies, gown qualification, training, and observation.