EMA Updated Q&A: Good Clinical Practice (GCP)

On 3 November 2020 the EMA added a new Q&A (#14) to the GCP matters section.

The EMA provides guidance in the form of questions and answers (Q&As) on GCP, as discussed and agreed to by the GCP Inspectors Working Group.

“Does the sponsor of a clinical trial have the right to audit the manufacturer of the investigational medicinal product (IMP) even if the manufacturer has been subcontracted by a contract research organization (CRO) involved in the clinical trial?”

The question touches the scope of GCP as well as the scope of GMP. The main aspects of the question are whether sponsor oversight, as defined in ICH GCP E6 (R2) also extends to the manufacturing area, i.e. a GMP area and whether the contract between the CRO and subcontractors should include (or implicitly permit) that a sponsor audit is possible not only at the CRO, but also at the subcontractor.

Read more online 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /