Galleries

Figure 1. USFDA three-stage process validation guideline, 2011 (Source: Ima Life)
Case Study Focusing on the Impact of Transient Pressure Excursions on Lyophilized Product Quality

Significance of Process Performance Qualification Approach for Process Validation

Process performance qualification (PPQ) runs are essential for ‘at-scale’ verification of the robustness of R&D lyo-processes, as these runs can often unravel challenges not encountered at the R&D scale. This case study exhibits the loss of pressure control in a commercial lyophilizer during PPQ runs of a parenteral product, its root cause analysis and finally, its resolution via remote PID-tuning performed by IMA Lab4Life scientists.

Read on