GMP Risk Analyses – gempex cooperates with Maas & Peither

Maas & Peither, the publisher specializing in Good Manufacturing Practice (GMP), and gempex, the GMP expert in the life science industry, are collaborating. Both have pooled their expertise and years of experience in the GMP environment to develop a novel tool for conducting risk analyses.

The focus was on the entire life science industry, including small and medium-sized enterprises as well as large global players — ranging from excipient suppliers to active ingredient manufacturers and pharmaceutical producers. The goal was to develop a tool for conducting risk analyses that saves users time and is easy and pragmatic to use.

The recently published first edition includes standard templates for three systems — ambient temperature storage, ventilation systems, and refrigerators — along with the corresponding sample SOP, which describes the how-to-do and seamlessly integrates into the GMP publisher’s SOP collection.

The approach and layout of the risk analyses were modeled on classic FMEA and adapted with the expertise of the involved specialists to meet the requirements of modern risk management. Wherever possible, "standard risks" from gempex’s extensive experience were incorporated and pre-illustrated.

Despite this, these standard templates still allow enough flexibility for specific adjustments and support the user in early error detection and avoidance. Nevertheless, gempex recommends that risk analyses be thoroughly developed and all risks discussed within a team. Every room and every system is individual and carries certain risks that must always be considered individually, with a focus on patient safety. The standard templates are intended to serve as a basis, discussion foundation, and reference for standard risks, but do not completely replace the execution of the risk analysis.

The GMP risk analysis package includes a well-organized, filled ring binder as well as the associated editable files for download (Excel and Word). A regular supplement and update service is available upon request. Future plans include additional systems related to the life science industry, such as mixers, autoclaves, etc.

Further information can be found at www.gmp-risiko.de.