Quality by Design

An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

A contamination control strategy should provide an overview of how contamination and containment practices work together to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

Quality Quartet Registers connect Quality Quartets to their process system or unit operation “parent.”

Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.

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

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.

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

The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.

Although not easy to do, it is essential because excipients can affect drug-product safety and efficacy.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about the difference between the roles of quality assurance and quality control.

Part 1 of this article series demonstrates, using real-world process data, that the four fundamental assumptions underlying the classical Shewhart control charts—randomness, independence, constant average, and constant variation—are often not met.

A data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.

Automated systems help detect and resolve quality issues.

Applying a QbD approach helps address excipient variability and other quality features.

Accelerated formulation strategies are a useful tool to reduce development timelines and cost, but key priorities must be considered early on to ensure success.

A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality.

Integrated, paperless data systems can improve efficiency and quality.

The need for real-time monitoring and control has spurred the development of new analytical tools.

Amid pressure to get more vaccines administered faster, FDA pushes back against changes in dosing regimens.

The collaboration addresses the need for risk mitigation plans in cell therapies.

A holistic approach to validation and quality assurance is essential.

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for solid oral dosage forms.

The use of analytical assays is crucial for determining that biosimilar critical quality attributes remain on point.

Dissolution testing is an important aspect of drug development as it provides stability parameters and helps predict drug behavior in-vivo.

Real-time monitoring and the principles of quality by design were used to optimize an OSD coating process.

Tools help improve understanding of excipient risk in formulating OSD drugs.

Focusing on symptoms instead of root causes locks teams into a corrective, rather than preventive, mindset.

Long a staple for quality by design and solid dosage form manufacturing, design of experiments is becoming an integral part of biopharma upstream process development.

Too narrow a focus on regulatory compliance may prevent organizations from embracing-and profiting from-quality and operational excellence.