Quality Assurance/Quality Control

Viral vectors and other complex biologic modalities require more specificity and higher sensitivity to detect and distinguish contaminants.

The growing use of continuous manufacturing in the pharmaceutical industry merits a review of the application of dry cleaning and sanitization methods, especially for non-sterile oral solid drug product manufacturing of dry powders.

Manual and automated inspection technologies have their own advantages and limitations.

The US Pharmacopeia’s Microbiology Expert Committee approved the inclusion of a chapter into the United States Pharmacopeia–National Formulary that allows the use of non-animal-derived reagents for endotoxin testing.

Using one system for test execution and sample management, improving right-first-time, and allowing review by exception can deliver access to key lab data faster.

This paper reflects upon the past 15 years of experience in the application of QRM and KM within the pharmaceutical GMP environment.

Life sciences data sets can be vast and complex to process, but up to now bringing intelligent automation systems up to speed and validating them has felt debilitatingly onerous. Large language models tackle these barriers head on. Ramesh Ramani and RaviKanth Valigari, technology innovators at ArisGlobal, explain.

Here, Pavan Kumar Kunala from Almac Sciences runs through the different types of tests used to analyze drug substances to ensure quality and safety.

A statistical analysis for determining an expiration date can be applied to replicates or their corresponding averages as suggested in industry guidelines.

The final drug product relies on the quality and reliability of the raw materials used in its production.

Lonza’s Joe Garrity and Jerry Jiang discuss the importance of not only automating CGT manufacturing, but also standardizing across processes.

EMA is promoting the use of RWD in decision-making and has started a public consultation to review its draft recommendations.

A combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.

Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.

This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.

Digital transformation is allowing for better handling, analysis, and protection of vast data collection.

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

Guidance documents and interaction with FDA can help manufacturers stay in GMP compliance, says Siegfried Schmitt, VP Technical, at Parexel.

In the new draft guidance, FDA provides recommendations on cell safety testing of human-sourced allogeneic cells for sponsor companies.

The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications.

The annual report details OPQ’s quality assurance work for 2023 including its support for the creation of guidance documents.

It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Compliance can be greatly improved by concentrating on the basic elements of CAPA investigations, advises Kate Rice, global quality systems manager, Nelson Laboratories, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.

The company is recalling one lot of the product because of the potential presence of silicone particulates.

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. Their digital transformation can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

IREM can be used for effectively assessing and mitigating risks and improving the overall sterility assurance level in all types of aseptic processing lines.

Regulatory submissions are a critical step in bringing new drugs and medical interventions to market, the success of which heavily relies on the quality and fitness of the data presented to the regulatory bodies.

This article explores the emergence of subjectivity in ICH Q9 (R1).

This article introduces that the basic technique for tolerance interval is implemented using the conventional range 85–115% LC where the proposed range in the PF is not taken into account.

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.