Our extensive experience in advancing projects

At Agno Pharma, we leverage our extensive experience in advancing projects from initial process discovery and pre-clinical stages to commercial API and drug product development using QbD principles. We ensure the delivery of your material at any development stage while simultaneously gaining process understanding and identifying the necessary controls for the PPQ (Process Performance Qualification) stage. Our approach includes phase-appropriate analytical method development, optimizing resource use, and focusing efforts where needed.

As projects progress to pre-PPQ and PPQ stages, we conduct thorough risk analysis, process characterization, and evaluation of process parameters and controls. We establish Critical Process Parameters (CPPs) and implement additional controls to ensure the robustness of the commercial process.

To support the QbD approach, we adhere to the latest ICH Q9 & Q11 guidelines. During pre-PPQ activities and beyond, we employ several methodologies to ensure compliance with QbD requirements, including:

• Failure Mode and Effects Analysis (FMEA)
• Design of Experiments (DoE)
• Risk Assessment and Mitigation
• Statistical Process Control (SPC)