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Updated ISPE guidance offers risk assessment guidance to avoid cross contamination in multiproduct pharmaceutical manufacturing facilities.
A new guidance document from the International Society for Pharmaceutical Engineering (ISPE) provides a scientific, risk-based approach for managing the risk of cross contamination within shared pharmaceutical manufacturing facilities.
The document, the ISPE Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products (Second Edition), aligns with the International Council for Harmonization (ICH) Q9 Quality Risk Management, and was developed in consultation with FDA and the European Medicines Agency. ISPE announced the new guidance on July 20, 2017.
“The use of multiproduct facilities for the production of pharmaceutical products requires an in-depth understanding of the products, the facilities, the processes, and the equipment and the risks posed by this combination,” said Stephanie Wilkins, ISPE guidance team co-lead in a press release announcing the guidance. “This Baseline Guide was created to assist manufacturers in assessing and controlling the risk of cross contamination posed by their combination of products, facilities, processes, and equipment so they are compliant with regulations and can confidently deliver products to patients in a safe, timely, and cost-effective manner.”
The guide describes a process for manufacturers to assess risk and determine where control strategies are needed to meet acceptable limits for cross-contamination. The guide is intended to offer a more consistent approach on setting acceptable limits to assess the potential of cross-contamination, ISPE reports.
Changes to the second edition include information about significant changes in regulations and the application of those regulations; reorganization of information to align with the ICH Q9 process; and an updated application example to increase understanding and experience with quality risk management, specifically with risk assessments for cross-contamination.
ISPE reports that FDA and EMA were actively involved in the guidance preparation and reviewed the document prior to publication.
The document reviews regulatory concepts and quality system requirements, as well as risk assessment, identification, analysis, control, evaluation, acceptance, management tools, review, and communication strategies.