Sampling and Analytical Record

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?

We critically review the qualification and validation approaches in the World Health Organization Technical Report Series (WHO TRS) 1019 Annex 3 and its applicability to spectrometer systems.

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?

The United States Food and Drug Administration (FDA) is using Remote Interactive Evaluations (RIE) to assess regulatory compliance, review submission material, or determine the timing of future inspections. Here, we look at some of the impacts of RIE on GxP laboratories. Although RIE is voluntary, is this an offer that you cannot refuse?

LCGC and Spectroscopy Editor Patrick Lavery spoke with Oligo Factory CEO Chris Boggess about the company’s recently attained compliance with Good Manufacturing Practice (GMP) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Expert Working Group (Q7) guidance and its distinction from Research Use Only (RUO) and International Organization for Standardization (ISO) 13485 designations.

Are the integrated Analytical Instrument Qualification (AIQ) and Computerized System Validation (CSV) new approaches to the qualification and validation of laboratory systems, or are they more of the same?