R.D. McDowall

A proposed update to United States Pharmacopoeia (USP) <1029> was published in July 2025 for industry comment. What’s changed and are the changes significant?

United States Pharmacopoeia (USP) general chapter <1058> on Analytical Instrument Qualification (AIQ) now has a new title from a draft update for public comment: Analytical Instrument and System Qualification (AISQ). A new three-phase integrated lifecycle phase approach to qualification and validation is described. But will laboratories and suppliers implement it?

Data process mapping is an effective way to identify data integrity vulnerabilities and remediate them. A modified example published by the Active Pharmaceutical Ingredients Committee (APIC) is reviewed critically. Can it be simplified?

It is traceability that shows that the ALCOA criteria does not exist in individual silos, but that they all interact with and are dependent upon each other.

Computerized system validation (CSV) has an uninspiring reputation for being a slow, no-value-added activity that only wastes time and delays the implementation of new software. Is that an accurate portrayal? And is it a necessary evil?

Some parts of the FDA’s new draft guidance for Development and Submission of NIR Analytical Procedures are reviewed and critiqued. What’s in it for spectroscopists?

A current hot topic in regulated GXP laboratories is data integrity. Recently, the UK regulator issued an industry guidance on this subject that requires the establishment of a data governance system, part of which is data integrity training. Easy to say, but how do you do it?

A proposed update to USP on Analytical Instrument Qualification (AIQ) has been issued for public comment. Here, we identify the changes that are proposed and their impact on the AIQ process of analytical instruments and laboratory computerized systems.

This month we discuss ISO Guide 80, "Guidance for the In-House Preparation of Quality Control Materials." This practical guide is worth reading, and its contents should be compared with your current working practices. In addition, we look at options for the preparation of working solutions from stock solutions to see the errors that could occur.

The European regulations on good manufacturing practices (GMPs) - Annex 11 - are having a strong influence on good laboratory practice (GLP) and good clinical practice (GCP).

The European regulations on good manufacturing practices (GMPs) - Annex 11 - are having a strong influence on good laboratory practice (GLP) and good clinical practice (GCP).

Paper is easy to archive, but what about archiving electronic records? What do you do with all the electronic records that are generated? In this month's installment, columnist Bob McDowall explores the issue of electronic records management and looks at the recent guidance issued by the OECD for GLP laboratories.

Using information provided by guidance documents from outside the spectroscopy laboratory can be very useful when trying to meet the regulations that we must follow.