Facing new global challenges, pharmaceutical company leaders are looking to prioritize operational strategies to remain competitive in this rapidly evolving business environment. Recent events that range from the COVID-19 pandemic to new regulatory guidelines to economic inflation have required pharma manufacturers to find new ways to streamline workflows and minimize risks. Disruptions caused by the pandemic and related restrictions continue to impact supply chains and logistics worldwide. Additionally, many companies have shifted toward remote and hybrid working, and have increased their use of digital technologies to maintain business continuity and protect the health of employees.

These changes are accelerating the need for new innovations. One solution is the use of intelligent informatics in the pharmaceutical quality control (QC) laboratory to improve the quality and safety of drugs and reduce the risk of costly errors and recalls. However, while technology can simplify many workflows, it also comes with a learning curve and new burdens may be placed on its users. Pharma companies must determine the effectiveness of technological advancements and the potential challenges they may introduce in an environment like pharmaceutical quality assurance/quality control (QA/QC).

BioPharm International’s March 2023 Quality and Regulatory Sourcebook eBook.

Mike Wilson, QA/QC Strategy, Waters Corporation

When referring to this article, please cite it as Wilson, M. Mitigating Human Error and Supporting Compliance with Smart Technology. 

BioPharm International’s Quality and Regulatory Sourcebook eBook 

Articles

Technological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.

Mitigating Human Error and Supporting Compliance with Smart Technology

Progressing a drug candidate from research to commercialization requires huge sums of money (approximately US$1.5 billion–$4.5 billion) (1) and is inherently high risk due to the high attrition rate. Only approximately 10% of total drug attrition is because of poor strategic planning or a lack of commercial needs (2). Highlighting solid strategy and funding alone is not enough to take a drug to market. Approximately 70–80% of clinical failures can be attributed to a lack of clinical efficacy or toxicity (3), and the majority of drug failures occurring in pre-clinical and Phase I are due to pharmacokinetics or toxicity issues (4).

Paul Van Tilborg is director of analytical sciences at Ardena.

When referring to this article, please cite it as Van Tilborg, P. Phase-appropriate Analytical Methodology. 

Analytics

A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.

Phase-appropriate Analytical Methodology

In parallel to the evolution of compendial and regulatory approaches addressing new quality paradigms for analytical procedure validation (discussed in Part I of this article), fundamentals of the quality-by-design (QbD) concept have been incorporated into the new International Council for Harmonisation (ICH) Q14 and ICH Q2(R2), which were recently released for public consultation. This article focuses on drawing parallels between ICH Q14/Q2(R2), 

) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.

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Amanda Guiraldelli is scientific affairs manager at the United States Pharmacopeia.
Jane Weitzel is an independent consultant and chair of the US Pharmacopeia Expert Committee on Measurement and Data Quality.

When referring to this article, please cite it as Guiraldelli, A. and Weitzel, J. Evolution of Analytical Procedure Validation Concepts: Part 2. 

BioPharm International Quality and Regulatory Sourcebook

Validation

This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.


Evolution of Analytical Procedure Validation Concepts: Part II

A safety surveillance strategy is a requirement for pharmaceutical companies to monitor product safety in the post-marketing environment, as well as to keep physicians informed on product risks and how to prescribe appropriately. This is usually seen as a labor-intensive cost center that often overburdens teams with work, making it difficult to retain talent. As the industry becomes more cost-conscious and is handling more real-world data sources than ever, companies are seeking ways to improve the efficiency and effectiveness of their pharmacovigilance (PV) activities. Automation offers the solution for organizations prepared to embrace it and to do the hard work required to support digital transformation.

Why automation is vital in pharmacovigilance

Many reasons exist to support the adoption of automation in drug safety surveillance. Using artificial intelligence (AI) in safety surveillance can automate many aspects of the process, including non-electronic data collection, processing of inbound data, and triaging data according to its source. With these applications, companies can increase productivity, lower their technology costs, and reduce their reliance on manual labor.

Read this article in the Quality and Regulatory Sourcebook 2023 

Updesh Dosanjh is a practice leader for technology solutions at IQVIA.

When referring to this article, please cite it as U. Dosanjh, "Pharmacovigilance Automation," 

BioPharm International's Quality and Regulatory

Organizations can better understand the maturity of AI-driven automation technology across their organization’s IT landscape through effective pharmacovigilance.

Pharmacovigilance Automation

In recent years, regulatory agencies have placed an increased emphasis on pharmaceutical process understanding through adoption of quality-by-design (QbD) principles by launching a series of initiatives to encourage the pharmaceutical industry to adopt QbD in the manufacturing process. A key component of this transformation is the evolution of validation concepts to a life cycle risk-based approach driven by analytical quality by design (AQbD) principles. Different pharmacopoeias have been developing compendial approaches to support the implementation of analytical procedure life cycle (APLC) risk-based approach. Additionally, the International Council for Harmonisation (ICH) released in March 2022 two draft guidelines for public consultation which outline QbD principles: ICH Q14 (procedure development) (1), and the ICH Q2(R2) (procedure validation) (2). In a series of two articles, the authors will provide an overview of the validation concept principles evolution with a focus on compendial perspectives (Part I) and draw a parallel between ICH Q14 and Q2(R2) and 

) General Chapter <1220> and the ISO/IEC 17025:2017 (Part II).

BioPharm International
eBook: Quality and Regulatory Sourcebook 2023
March 2023
Pages: 14–21

When referring to this article, please cite it as Guiraldelli, A. and Weitzel, J. Evolution of Analytical Procedure Validation Concepts: Part I. 

This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives.


Evolution of Analytical Procedure Validation Concepts: Part I

Biopharma systems and processes are outlined in the introductory section of this monograph. A new knowledge management (KM) paradigm is then described, beginning with an analysis of United States and European Union regulatory requirements, and of prevailing commissioning and qualification (C&Q) and quality risk management (QRM) guidance from the International Society for Pharmaceutical Engineering (ISPE) and International Council for Harmonisation (ICH).

The KM paradigm is a response to the expectation that C&Q and QRM be integrated and accelerated, on urgent fast-track projects (the new normal) in particular. It is based on pattern recognition, and on the insight that process-related critical quality attributes (CQAs) and critical process parameters (CPPs), and plant-related critical aspects (CAs, or functions) and critical design elements (CDEs, or components), are best managed via a previously unrecognized fundamental object called quality quartet, comprising CQA:CPP:CA:CDE parts. Several well-established and universally accepted benchmarks are listed in support of the paradigm.

Cliff Campbell is senior consultant at KPC.

When referring to this article, please cite it as Campbell, C. Points to Consider for Knowledge Management Acceleration. 

Knowledge Management

Quality quartets support an integrated and stable combination of
commissioning and qualification and quality risk management processes.

BioPharm International Quality and Regulatory Sourcebook 2023

Mitigating Human Error and Supporting Compliance with Smart Technology

Phase-appropriate Analytical Methodology

Evolution of Analytical Procedure Validation Concepts: Part II

Pharmacovigilance Automation

Evolution of Analytical Procedure Validation Concepts: Part I

Points to Consider for Knowledge Management Acceleration