Process Characterization (PC) and Process Validation (PV)

Mycenax adheres to the three Process Validation (PV) stages from the latest regulator guidances, starting with a product-specific master plan. The stages include Process Design (PD, Stage 1), Process Performance Qualification (PPQ, Stage 2), and Continued Process Verification (CPV, Stage 3), covering all process performance metrics. This strategy is based on Quality by Design (QbD) principles and incorporates risk-based control to enhance lifecycle knowledge and continuous improvement, serving as Mycenax's guiding principles for consistent manufacturing performance.

Service Highlights

Regulatory Inspections Experience

Successfully passed EMA, MHRA, PMDA, Health Canada and MFDS GMP inspections.

Global Quality System

120+ regulatory inspections and client audits globally.

PC & PV Expertise

Over 10 years of proven experience delivering customized solutions to meet client goals.

Three-stage Process Validation Strategy to Accelerate Your Drug to Market

CH-Aligned Process Characterization & Validation

Our PC/PV approach follows key ICH guidance (Q8–Q11), ensuring scientific understanding, risk-based control strategies, and robust process demonstration for regulatory compliance and commercial readiness.

Stage 1: Process Design Based on QbD Principles 

Based on critical quality attributes (CQAs), we define unit operations with specific objectives for each step. This involves characterizing process capabilities and establishing an operating design space, along with material and process control strategies. Mycenax aims to build process knowledge and enhance understanding of process capabilities in Stage 1.

STAGE 2: Process Qualification

At this stage, the process design is put into action to ensure consistent manufacturing performance. Both facility and equipment and process parameters are validated to ensure confidence in manufacturing outcomes. While the number of batches is a common validation criterion, it is not the only one, though it provides valuable at-scale data to supplement the validation package.

STAGE 3: Process Monitoring

Following a successful PPQ, a CPV program is essential to maintain control over the manufacturing process, especially with fewer than 30 batches. Hence, a CPV plan plays a vital role as a commitment with a prospective plan to monitor the CPP, IPC, lot release results, undesirable process variabilities, and opportunities for process improvements based on the knowledge gained from the previous stages or reviews.