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By Maria Wik, MS
VP, CMC Development

The ICH Q10 definition for a Control Strategy is: “A planned set of controls, derived from current product and process understanding, that assures process performance and product quality.” Understanding the essence of a process control strategy directly addresses a critical challenge faced by many in the biologics manufacturing industry: ensuring high-quality products while navigating a dynamic manufacturing environment.

Establishing and maintaining a process control strategy are critical steps in biologics manufacturing to ensure that the biological product consistently meets the required quality standard. The process control strategy is a living element that evolves throughout the product lifecycle.

The birth of the strategy takes place during stage 1 of Process Validation, referred to as Process Design. This is where the understanding of the product and process informs its development. During stage 2 of Process Validation, referred to as Process Qualification, the process control strategy is verified through the execution of Process Performance Qualification (PPQ) runs. This validation process ensures alignment with the intended performance objectives.

The process control strategy doesn’t remain confined to mere documentation, it reaches regulatory recognition. It is described in the Regulatory dossier submission(s) and is approved by regulators.  Its components are viewed as binding commitments.

During stage 3 of Process Validation, the Continued Process Verification (CPV) stage, the process control strategy remains crucial to sustain both product quality and process performance. The strength of your process control strategy becomes apparent when addressing deviations and managing changes during the commercial production phase. Having a well-developed and well-documented process control strategy provides a comprehensive summary of process understanding. Documented in-depth understanding of process behavior allows for timely and thorough deviation investigations and the implementation of robust CAPAs.

How is a process control strategy developed and maintained?

Process and Product Development groups are typically responsible for the creation of a process control strategy using a science and risk-based approach based on product and process understanding.

The quality target product profile (QTPP) serves as a guiding principle for the product’s development. It identifies Critical Quality Attributes (CQAs) that lay the foundation for the strategy’s formulation.  The Process Design phase explains interplay between material attributes, process parameters, and CQAs.  The subsequent process characterization studies further unravel sources of process variation and their implications on performance and quality attributes, contributing to the establishment of the initial process control strategy. During the PPQ stage, the strength of the strategy is tested. Multiple tests confirm whether the strategy, as designed for the manufacturing process, is competent to consistently generate a product of desired quality under real-world conditions.