Sampling and Analytical Record

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.

A look at two ICH draft publications reveals that the EWG has much revision work to do for these publications to fully cover the validation lifecycle process.

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.