Quality Assurance/Quality Control

The authors provide an overview of the new ISPE Guide Series on Product Quality Lifecycle Implementation and how the guides can be used in a complementary way with existing guidance from FDA and the International Conference on Harmonization.

The authors detail the possible consequences of noncompliance and a lack of quality control.

CML - Quality Assurance

Where is the variability coming from and what have we done to minimize it?

Precedents set in the historic Barr case continue to raise questions over suitable sample-size criteria.

Current GMPs demand full understandng of out-of-control concepts. This article contains bonus material.

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?