Quality Assurance/Quality Control

Glass flaking or delamination can result in a failed quality-assurance test, thus bringing production to a halt and causing substantial revenue loss. If glass delamination remains undiscovered, it can pose a serious contamination risk to the drug product and a potential health risk to the public.

A summary of the latest steering committee and expert working groups' meeting.

A firm grasp of probability and ongoing re-evaluation are key.

A book about developing quality-control training manuals provides a wealth of information and a dearth of practical help.

A PQRI expert working group provides case study examples of risk-management applications.

Ensuring compliance though increased statistical knowledge and resources.

The hardest errors to spot are the ones that don't look like errors at all.

The United States Pharmacopeial Convention (USP) launched a 12-month pilot Technical Assistance Program (TAP) to provide developing countries in sub-Saharan Africa with greater capacity to test the quality of medicines.

Using risk assessment properly can provide industry with a unique tool for quality control.

The authors discuss the role of quality-control automation in providing better data, enhanced compliance, and potentially faster release times.

Applied statisticians are forever searching for the enemy of quality-variability.

The author outlines key considerations for carrying out a structured approach to monitoring process performance and ensuring product quality.

To properly inspect based on measurement, a reference standard is crucial for comparison.

The Laboratory Services Division of the Philippine Food and Drug Administration (FDA) has attained internationally recognized accreditation for its testing and calibration laboratories, according to a July 12, US Pharmacopeia (USP) announcement.

A history of the selection of the widely used significance level leaves much to be desired.

The 2D Data Matrix barcode is a familiar sight for most pharmaceutical manufacturers as printing is implemented to meet certain regulations.

A method for determining sample size is finally getting some respect.

Liquids are used in a wide variety of industries, either during manufacture or as end-products in themselves. Whatever the end product, quality control of liquids is crucial to many industries.

Leading experts share insight on the current and future direction of process analytical technology. This article contains bonus online material.

Grace McNally, in the Office of Compliance at FDA's CDER, discusses the role of QbD and pharmaceutical quality systems as it relates to contract manufacturing.

The quality assurance environment is forcing pharmaceutical companies to face new challenges. In light of this, the authors conducted a study of professionals from some of the world's top pharmaceutical companies to identify key QA concerns.

Is the square root of (N) + 1 a statistically valid scheme?

The author of an ambitious book about quality control falls short of reaching his goals.

A book guides readers through the regulatory requirements for computerized quality systems.

Myth versus Reality: What does Q10 implementation really mean for my company?

A new book explains process analytical technology, drug stability, and quality.

Process designs and control strategies can be improved by adopting a risk-based approach to product quality. The author describes how this approach can be applied to spray-drying operations.

QbD, PAT, design space, what's it all about? This seems to be a common industry response to FDA's directional push.