Linking CQAs, CPPs and in process controls in a traceable framework Linking CQAs, CPPs and in process controls in a traceable framework This article serves as a regulatory explainer manual for Kharma and regulatory professionals focusing on the CMC lifecycle management with an emphasis on the control strategy involving Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs). We will explore the regulatory expectations and guidelines applicable across the US, UK, and EU, providing a detailed overview of best practices and common deficiencies to avoid in regulatory submissions. Context In the pharmaceutical and biotechnology industries, the control strategy is a…

Using Risk Assessment to Select Critical Process Parameters for Control Using Risk Assessment to Select Critical Process Parameters for Control The selection and management of critical process parameters (CPPs) play a pivotal role in the development of a robust control strategy within the context of CMC lifecycle management. In the pharmaceutical and biotech industries, a scientifically sound approach based on risk assessment is essential to ensure the quality and consistency of drug products. This article serves as a regulatory explainer manual focused on utilizing risk assessment methodologies to inform the identification and selection of critical quality attributes (CQAs) and CPPs,…

Case studies of weak control strategies cited in health authority feedback Case studies of weak control strategies cited in health authority feedback In the pharmaceutical and biotech industries, the implementation of a robust Control Strategy is essential for ensuring the consistent quality of drug products. Regulatory Agencies, particularly in the US, UK, and EU, have issued guidelines that emphasize the importance of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) as pivotal components of Quality by Design (QbD). Misalignment in these areas can lead to significant deficiencies during regulatory review. This article presents an in-depth examination of regulatory expectations…

Aligning Control Strategy with PAT, RTRT, and CPV for Lifecycle Robustness Aligning Control Strategy with PAT, RTRT, and CPV for Lifecycle Robustness In the realm of pharmaceutical and biotech industries, ensuring the quality and efficacy of drug products through stringent regulatory frameworks is paramount. Central to this effort is the concept of the Control Strategy, which integrates Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs). This article aims to guide regulatory affairs professionals on aligning these concepts with Process Analytical Technology (PAT), Real-Time Release Testing (RTRT), and Continuous Process Verification (CPV) to enhance lifecycle robustness under the regulations of…

Control strategy for highly variable and complex biologics processes Control strategy for highly variable and complex biologics processes Regulatory Affairs Context The landscape of biopharmaceutical development is increasingly complex, particularly regarding the manufacturing of biologics. A robust control strategy that addresses critical quality attributes (CQAs) and critical process parameters (CPPs) is essential for ensuring product quality and regulatory compliance. The development and maintenance of a CMC (Chemistry, Manufacturing, and Controls) control strategy are crucial for the successful regulatory submission and approval process in various jurisdictions, including the US, EU, and UK. Legal/Regulatory Basis Regulatory frameworks governing biologics are predominantly outlined…

Tools and templates for visualising control strategy in CMC dossiers Tools and templates for visualising control strategy in CMC dossiers Regulatory Affairs Context The control strategy within the Chemistry, Manufacturing, and Controls (CMC) section of regulatory submissions is a fundamental component that ensures product quality throughout the lifecycle of pharmaceutical and biotech products. A well-defined control strategy delineates how critical quality attributes (CQAs) and critical process parameters (CPPs) will be monitored and controlled to ensure product consistency and compliance with regulatory requirements. This article seeks to provide a comprehensive overview of the tools and templates available for effectively visualising control…

Updating control strategy after major process changes and tech transfer Updating Control Strategy After Major Process Changes and Tech Transfer The landscape of pharmaceutical manufacturing is continuously evolving due to technological advancements, regulatory changes, and process optimization. As such, managing the Control Strategy is critical for ensuring consistency, compliance, and product quality. This guide focuses on the regulatory expectations surrounding the updating of control strategies, particularly in the context of major process changes and technology transfers, aligning with the mandates of the FDA, EMA, MHRA, and ICH guidelines. Regulatory Affairs Context Control Strategy is a fundamental element in Quality by…

Leveraging platform control strategies across related product families Leveraging platform control strategies across related product families In today’s rapidly evolving pharmaceutical landscape, the effective management of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) is essential for maintaining product quality and regulatory compliance. By establishing robust CMC control strategies, pharmaceutical companies can streamline their development processes and enhance product lifecycle management. This regulatory explainer manual provides a structured approach to understanding the guidelines and expectations surrounding CMC control strategies across related product families in the US, UK, and EU. Regulatory Affairs Context Regulatory Affairs (RA) professionals play a critical…

Regulatory expectations for justification of CPP ranges and set points Regulatory expectations for justification of CPP ranges and set points Context The control strategy (CS) defined within a product’s CMC (Chemistry, Manufacturing, and Controls) documentation plays a pivotal role in ensuring the quality of pharmaceutical products. Central to this control strategy are critical quality attributes (CQAs) and critical process parameters (CPPs). CQAs are the physical, chemical, biological, or microbiological properties or characteristics that must be controlled throughout the manufacturing process to ensure the desired product quality. CPPs, on the other hand, are the parameters that influence the CQAs and must…

Integrating Device and Container Closure Controls into Product Strategy Integrating Device and Container Closure Controls into Product Strategy In the realm of pharmaceutical and biotech product development, a comprehensive understanding of the CMC (Chemistry, Manufacturing, and Controls) lifecycle management is pivotal. This article delves into the integration of device and container closure controls into product strategy, specifically focusing on critical quality attributes (CQAs) and critical process parameters (CPPs). Regulatory expectations from agencies such as the FDA, EMA, and MHRA will be examined, providing a detailed resource to facilitate the successful registration and maintenance of pharmaceutical products. Context The integration of…