The "OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING" document No. 22 is a comprehensive, well-written, fluently readable guide to data integrity in the Good Laboratory Practice area.
In the course of an expansion, the IRIS platform will also be used by marketing authorisation holders and applicants to communicate with the EMA about GMP inspections.
The Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) has published a Draft Guidance for Industry entitled "Questions and Answers on Quality Related Controlled Correspondence". The document contains, besides other topics, questions and answers related to bracketing and matrixing.
The US FDA reports deficiencies during inspections in the so-called Form 483s. These reports are partly public, and the FDA subjects them to trending by key points. The evaluation of the last year 2020 shows a significant increase in inspection deficiencies with regard to equipment.
The frequent occurrence of particles in sterile injection solutions and the inadequate investigation of the cause led to a Warning Letter to a sterile manufacturer in Japan. In addition, data integrity breaks and falsifications had occurred in the environmental monitoring.
The FDA has published guidance to clarify how considerations about benefit-risk assessment are integrated into the agencys pre- and postmarket decisions for marketing applications. Read more about FDAs draft guidance on Benefit-Risk Assessment for New Drug and Biological Products.
The FDA published a new draft guidance on the responsibilities regarding safety reporting for investigational drugs and devices. What is required for investigational device exemption studies?
The European Commission sets new limits for Cadmium and Lead in certain Foodstuffs and Food supplements. Products placed on the market before the entry into force of the new regulations and not complying with the new maximum levels should only be allowed to remain on the market for a limited period of time.
The European Commission has proposed further arrangements to respond to possible difficulties in the movement of goods between Northern Ireland and Great Britain
The Brazilian Health Regulatory Agency (ANVISA) has published a list of cannabis products that will have automatic approval by the agency for individual importation by Brazilian patients. The list also includes a large number of CBD preparations.