Control Strategy: A Feedback-Feedforward 'Controls Hub' for Risk, Knowledge, and Product Lifecycle Management

• Published in: Pharmaceutical Technology 2023-10, Vol.47 (10), p.30-46
• Main Author: Ramnarine, Emma
• Format: Magazinearticle
• Language: English
• Subjects: Feedback control systems; Feedforward control systems; Good Manufacturing Practice; Influence; Internal customers; Knowledge management; Management; Manufacturing; Pharmaceutical industry; Pharmaceuticals; Process controls; Product development; Product life cycle; Product management; Product quality; Product testing; Production management; Quality management; Technology transfer
• ISSN: 1543-2521; 2150-7376

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) defines product lifecycle as "All phases in the life of a product from the initial development through marketing until the product s discontinuation," in ICH Q8(R2), Pharmaceutical Development (1), and laid out the following three primary objectives throughout the product lifecycle in ICH Q10, Pharmaceutical Quality System (2): * Achieve product realization (i.e., deliver products with the quality attributes appropriate to meet the needs of patients, health care professionals, regulatory authorities, and internal customers). * Establish and maintain a state of control (i.e., use effective monitoring and control systems for process performance and product quality, thereby providing assurance of continued suitability and capability of processes). * Drive continual improvement (i.e., implement appropriate product quality and process improvements, variability reduction, innovations and PQS enhancements, thereby increasing the ability to fulfill quality needs consistently). [...]ICH Q10 refers to quality risk management and knowledge management as enablers (i.e., "processes that provide the means to achieve an objective" [2]), the objective being consistently producing a product of the required quality. The paper discusses what a control strategy is, including its components, why it is important to start its design during the first stage of the product lifecycle (pharmaceutical development), how it should evolve during the next stages of the lifecycle (technology transfer and commercial manufacturing), what does a control strategy look like for outsourced operations (i.e., contract development and manufacturing), how the control strategy can provide a feedback and feedforward mechanism for knowledge and risk-informed decisions, and, finally, how to manage the control strategy through a cGMP-compliant pharmaceutical quality system (PQS) in order to keep it "living". [...]there is limited guidance on how to implement all of these related concepts in an integrated manner for a single product, let alone to optimize sharing and use of knowledge across multiple products.