GMP NEWS 2015

The "FDA Voice" is a Blog which has been developed by the US Agency to post current initiatives, presentation and views. In a recent post published on March 24, 2014 Howard Sklamberg and Cynthia Schedar discuss ideas to improve the quality of inspections. Read more about the new FDA inspection appraoch.

With the new biocidal products regulation from 2013 in-situ generated ozone now also falls into the scope of this directive. Ozone generation systems with a biocide application (such as disinfection of pharma water) thus require an approval after the transitional period expires in the September 2017. The ozone registration group is active for this purpose. Read more about the Ozonization of Pharmaceutical Water and the Biocidal Products Regulation.

As one of the consequences from the Counterfeit Directive a European wide authorisation and monitoring system has been established. Each Wholesaler will need a Wholesale Distributor Authorisation (WDA). Those facilities that have been audited will receive a GDP certificate. Please read more about the WDAs and GDP certificates in EudraGMDP.

The MHRA has published a revised set of documents which are part of the risk based inspection system of the GMP Inspectorates in the UK. These documents are intended to help MHRA to get information prior to an inspection. Please read more about the MHRA risk ranking and the required Reports.

When the layout is developed, in other words when the decision is taken which processes will be carried out in which premises and how the future flows of personnel and material will take place the dimensions of the required HVAC system will also be determined. This is a new point of view in times of increasing energy costs and of the need to reduce CO2 emissions. Read more about the clean room concepts and their impact on the HVAC technology.

In the past, the ECA has often reported about the Unique Device Identifier topic. In the meantime the Unique Device Identifier (UDI) and Global Unique Device Identification Database (GUDID) topics have taken on great importance at the FDA. Read more about the FDA presentation slides on UDI and GUDID available on the FDA website.

In 2014, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) published the revision of two annexes of their GMP guide, relevant  for blood and biological products. Read more about the Revision of relevant PIC/S Guidance Documents in 2014.

In January CBER published an overview about the planning of the development and teh revision of guidances in the field of blood, tissues and cellular products. Read more about the Guidance Documents CBER is planning on publishing.

In the Pharmacopeial Forum the USP presented the new General USP Chapter <1210> on Statistical Tools for the Validation of Analytical Procedures. Get more information on the Chapter <1210>.