Quality Assurance/Quality Control

CBER maps modernization plan to handle surge in research and applications.

Production of viral vectors requires a holistic view of the product, including its manufacturing process and its ultimate end use.

This article introduces a control chart technique using F statistic for continued process verification of oral solid dosage forms.

A blended approach to newly revised regulatory guidance to inform environmental monitoring programmes is essential.

Under the revised NIS-2 Directive in Europe, pharma companies will need to be proactive in safeguarding their digital assets.

FDA backs joint reviews, common research policies, and modern production methods around the world.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, addresses the difference between regulatory compliance and real compliance.

Choosing low-adsorption glass vials helps ensure detection accuracy.

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.

A process flow diagram can help create an agreed-upon process flow for a third-party standard operating procedure, says Siegfried Schmitt, VP Technical at Parexel.

Pharmaceutical Technology spoke with Andrew Anderson, Global Head Strategic Account Management and Mary Todas, Director Technical Development and Regulatory Affairs, both with Pfizer CentreOne, about best practices for API quality.

Pharmaceutical Technology spoke with Niamh Lynch, Executive Director, Global Head of Quality, Lonza Small Molecules, Basel about best practices for API quality and the impact of the nitrosamine contamination situation.

The nitrosamines contamination in “sartan” drugs emphasized the importance of risk assessment in the manufacture of active pharmaceutical ingredients.

This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.

Screening for apparent total nitrosamine content with a thermal energy analyzer offers a rapid way of identifying contaminated drug products.

Pharmaceutical Technology Europe spoke with representatives from the European Directorate for the Quality of Medicines & Healthcare (EDQM) about API quality from their perspective.

Pharmaceutical Technology spoke with Ed Gump, VP Small Molecules at the US Pharmacopeia (USP) about API quality from the standards perspective.

Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate.

Exhibitors display innovations for parenteral and solid dose products.

Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.

An SOP for electronic-records archiving is a regulatory requirement and good for business, says Siegfried Schmitt, vice president, Technical at Parexel.

This article describes the in-vitro permeation test study data processing procedures and FDA statistical mathematics of evaluating a generic topical drug product, acyclovir cream, against its reference product.

This article explores the concerns with cleaning pharmaceutical products utilizing LNP delivery vehicles and provides a general cleaning recommendation based on laboratory and field testing.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the basics for maintaining an acceptable working relationship between a client and their CDMO.

FDA continues efforts to incentivize drug manufacturers to follow higher data integrity requirements.