GMP NEWS 2018

The overall responsibility for clinical trials lies with the sponsor. Whereas activities may be contracted or delegated, responsibility itself can not. Read more about metrics and case studies from GCP inspections with regard to sponsor oversight of clinical trials.

The brand-new 2018 edition of the Defect Evaluation List for Containers Made of Moulded Glass which includes an appendix with example pictures of specific defect characteristics is out now.

The API manufacturer Keshava received a Warning Letter from the FDA in March 2018. During the inspection, it has been criticised that no corrective actions had been taken for Out-of-Specification results and that a few analyses missed complete data. Read more here about the FDA Warning Letter for Keshava Organics.

FDA published their recommendations for further testing if the result of a donor screening test for antibodies to the hepatitis C virus (anti-HCV) came out positive. These recommendations may be found in the draft guildeline on "Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus".

Relating to the increasing need of simultaneously evaluatation of more than one investigational drug and/or more than one cancer type in one clinical trial, the FDA published a new guidance on Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.

The FDA published a new guideline on the selection of the appropriate package type terms and recommendations for labeling injectable medical products packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use.

Recording temperatures during transport of pharmaceutical products as well as calculating the mean kinetic temperature is essential for assessing a batch with regard to its quality status. How to avoid mistakes when calculating the mean kinetic temperature?

The MHRA recently updated their Good Pharmacovigilance Practice (GVP) webpage on the MHRA website. In addition, the agency provided important things to know about GVP inspectors and GVP inspections.

The EDQM published a draft for a new Ph. Eur. general chapter regarding pyrogen inactivation or removal from primary packaging materials and equipment. Read more about depyrogenation of items used in the production of parenteral preparations.