Chromatography Data System

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?

The publication of a new FDA compliance policy for pre-approval inspections (PAIs) introduces a new objective to inspect research and development in pharmaceutical development. We explore how this could influence the PAI process now.

Now that the draft FDA guidance on computer software assurance (CSA) is out, we can see what it is—and is not.