GMP NEWS 2016

Recently, the FDA has published a draft guideline on the determination of Quality Metrics. With regard to medical devices, the FDA is now pursuing a similar path. Under the heading "Case for Quality" (CfQ), the FDA would like to improve the quality of medical devices.

As part of its inspections, the FDA nowadays always examines the integrity of data. This can clearly be seen in the recent Warning Letter from December 2015. Besides, the letter focuses on the inappropriate handling of OOS results. Read more about the current FDA Warning Letter on Data Integrity. 

The European Medicines Agency (EMA) has revised several modules and documents of the Guideline on good pharmacovigilance practices (GVP) and published them for comment, i.e. finalised a document. Read more about the GVP updates.

The FDA adopted and published the Guidance for Industry "Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products". Read more about these FDA recommendations.

Two FDA draft guidances regarding INDs have been published for comments in December 2015: "Best Practices for Communication Between IND Sponsors and FDA During Drug Development" and "Safety Assessment for IND Safety Reporting". Find out more about the draft guidances on investigational new drug applications (INDs).

The FDA has recently published a new Guideline as a draft which describes the certification process of medical gases i.e. gases for direct administration to human beings or animals. Read more about the FDA Medical Gases Certification Guideline.

The MHRA GPvP inspectorate published their latest inspection metrics report for the period of April 2014 to March 2015. Read more about the findings identified during all 48 inspections conducted during this period.