R.D. McDowall

United States Pharmacopeia (USP) general chapter 1058 on analytical instrument qualification (AIQ) has finally become official and was released in August 2008 in the first supplement to the USP XXXI.1 This column reviews AIQ and discusses the impact it will have in the regulated chromatography laboratory.

This column discusses the similarities and differences between the validation approaches for analytical methods for QC product analysis and bioanalysis.

The regulatory world and associated guidance documents within the pharmaceutical industry is changing rapidly. This column gives an overview of what's happened since the start of the year.

You may work in a chromatography laboratory to quality standards but do you work to Good Laboratory Practice? Probably not...

The four eyes approach is a cornerstone of any quality system (GMP, GLP or ISO 17025): a first person performs a task and a second person checks it.

Users need to understand not only the operation of the computer system as required by their access privileges, but also the ethics and integrity required operating under any of the GMP or GLP quality systems.

The fundamental aim of any computerized system validation should be to define its intended use and then test it to demonstrate that it complies with specification.

The best parts of the GAMP laboratory system GPG are the life cycle models for both development and implementation of computerized laboratory systems.

Part 2 of the column explores using the right balance for the right job in the right way.