Drug Development

Articles

Risk analysis and evaluation of software and computer systems is a good tool to optimize validation costs by focusing on systems with high impact on both the business and compliance.

Risk-Based Validation of Commercial Off-the-Shelf Computer Systems

Performing studies to mathematically 'correlate' swab and rinse sampling values does not add any value. What's more, do not expect them to mathematically correlate.

Dispelling Cleaning Validation Myths: Part I

Formulation residue, observer viewing distance, light intensity, viewing angle, observer viewing position, and observer-to-observer variability affect the ability to confirm the cleanliness of manufacturing equipment.

Application of Visible-Residue Limit for Cleaning Validation Richard J. Forsyth and Vincent Van Nostrand

Application of Visible-Residue Limit for Cleaning Validation

Manufacturers can take steps to establish a regulatory compliance assessment program in their pharmaceutical manufacturing facilities.

Regulatory Compliance Review

It was, our GMP Agent-in-Place recalls, a typical, small, clinical-type facility... managed in the typical, informal way.

Broken Records and Red Eyes

Although agitation improves drying efficiency and ensures uniformity of the final dry material, it can also affect the physical properties of the product as it dries. This study evaluates the effect of scale up and equipment selection on an active ingredient undergoing granulation during the drying process.

Scale Up of a Granulation Phenomenon

Warning Letter: Similasan

Technology's new monthly "Agent-in-Place" column distills true-life cautionary tales from the secret files of Control, a senior compliance officer.

Wash. Rinse. Repeat

The European Commission has released its second report to the Council and European Parliament addressing the developments and implications in patent law concerning biotechnology and genetic engineering. The study, which centres on the patentability of inventions relating to stem cells, concluded that those capable of developing into human beings, totipotent stem cells, are to be excluded from patentability on the Directives' grounds of human dignity.

Process and Scaling