In February 2019, the WHO published a new Guideline for comment on the production of WFI using non-distillation methods. Read more about the draft entitled "Production of Water for Injection by Means other than Distillation".
Data from pre-clinical/clinical studies are often not sufficient for a comprehensive qualification of impurities with regard to their biological safety profile. The new EMA Reflection Paper provides guidance for determining the safety profile of impurities by means of various methods.
The FDA strengthens the process for issuing a public warning about a voluntary recall and for notification of recalls. Read more about FDA´s final guidance on Public Warning and Notification of Recalls.
In response to the increasing need for a guidance paper for radiopharmaceuticals in non-clinical settings, the EMA has published a "Draft guideline on the non-clinical requirements for radiopharmaceuticals".
In January, the FDA published a guide on immune responses to protein products: "Immunogenicity testing of therapeutic protein products - Development and validation of assays for the detection of antidrug antibodies".
In January 2019, the World Health Organization (WHO) and the International Atomic Energy Agency (IAEA) published a draft guideline dealing specifically with the GMP requirements for the manufacture of radiopharmaceuticals.
The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 1: Must there be a concept for evaluating the criticality of data? And what rules for entering critical data into computerised systems must be available? The answers to both questions can be found here.
The EMA recently released comments gathered during its public consultation for the ICH Q12 draft guideline. Read more about EMA ´s overview of comments received on ICH Q12 on pharmaceutical product lifecycle management.
A Non-Compliance Report due to several GMP violations has been issued to a Chinese heparin manufacturer after an inspection conducted by the Italian Health Authority. This report is now available on the EMA website for Non-Compliance Reports.