GMP News - Pharmaceutical Development / Clinical Trials / GCP

More than one year after the publication of the ICH Q3D Guideline on "Elemental Impurities" as "Draft Consensus Guideline" (Step 2B document), the final Guideline has now been released. Compared to the draft of 2013 the main changes relate to the limits of the daily absorption of metallic impurities in the different dosage forms. Read more here.

On 23 October, the CHMP adopted the revised Guideline on similar biological medicinal products. Get more details here.

The European Commission has published the new EU GMP Chapter 8 on Complaints, Quality Defects and Product Recalls. The chapter has been revised completely and details additional requirements for recalling investigational medicinal products (IMPs). Read more.

Related to the possible risks of immunologically based adverse events, the FDA published a "Guidance for Industry Immunogenicity Assessment for Therapeutic Protein Products". Read more here.

The EMA GCP Inspectors Working Group has published the Procedure for coordinating GCP inspections requested by the CHMP describing the  the different steps of the Good Clinical Practice (GCP) inspection process. Read more.

The release of Investigational Medicinal Products (IMPs) or Clinical Trial Material (CTM) for clinical trials in the EU can be very complex. Read here what needs to be considered.

Following the positive vote in Parliament for the new Clinical Trial Regulation, the EU Commission has published a set of Q&As on clinical trials. Read more.