PDE Report | Sample Document

Artificial intelligence is becoming increasingly important in GMP-regulated environments, presenting companies with new regulatory challenges. This article summarizes the latest regulatory developments, introduces a validation framework based on the FDA's seven-step model, and outlines initial practical experience with AI/ML validation.

EMA reported that Scholar Rock Netherlands withdrew its application for Isembyld after evaluation had progressed through the final round of questions. EMA’s provisional view was that the medicine could not be authorised because the applicant had not provided confirmation that the manufacturing site complied with EU GMP requirements.

Supplier management is the systematic management of a company´s relationship with its suppliers. It encompasses supplier qualification and customer audits as described in the following excerpt from GMP:KnowHow Pharmalogistics (GDP).

On 14 August 2026, the US Food and Drug Administration (FDA) announced the publication of a new draft guidance document entitled ‘Container Closure Systems for Human Drugs and Biological Products’.