Mitigating Cross-Contamination in Shared Production Facilities Using Risk-Based Cleaning Validation Methods: Considerations and Case Study. December 2018
(2018; 21 pages)

Mehta J, Nkansah P, Clark A. Mitigating Cross-Contamination in Shared Production Facilities Using Risk-Based Cleaning Validation Methods: Considerations and Case Study. 2018. Promoting the Quality of Medicines (PQM) Program. US Pharmacopeial Convention. Rockville, Maryland.

Resumen

This report provides an essential overview of the evolution of the regulatory expectations and industry advances in cleaning validation (CV) approaches, including recent risk assessment considerations. CV has become a regulatory requirement for preventing potential cross-contamination of products manufactured in the same equipment train in the European Union, the United States, Canada, Japan, and elsewhere. The need for CV approaches for priority essential medicines is especially important given the limited commercial value and interest of manufacturers in such products.

For priority essential medicines to be eligible for procurement by international donors, manufacturers must demonstrate their products were manufactured in compliance with international good manufacturing practice (GMP) standards such as those developed by the WHO Prequalification (WHO PQ) Program. Avoiding cross-contamination during manufacturing is a critical component of GMP; at a minimum, pharmaceutical manufacturers must generate CV data for the worst-case product to be manufactured using undedicated equipment to demonstrate that the potential for cross-contamination is minimized.

Compliance with current GMP requirements can be an expensive investment for manufacturers, sometimes requiring them to build separate facilities for products that are hazardous for contaminating other products. This is particularly true for public health essential medicines that offer small margins. However, conducting thorough risk assessments and employing effective risk mitigation strategies may help manufacturers, particularly those in low- and middle-income countries, effectively manage the potential for cross-contamination and fulfill international regulatory requirements.

This report provides important financial rationale and regulatory justification for manufacturers of priority essential medicines to maintain a robust CV program and conduct a risk mitigation strategy for minimizing cross-contamination. It includes a case study and examples that demonstrate how to (1) successfully mitigate risks of handling a product (in this case, cyclosporine) in a multiple product manufacturing facility, and (2) leverage existing CV approaches toward the recent health-based CV limit regulatory requirements. The methodology outlined in this report should serve as a guide for manufacturers endeavoring to manage the risk of cross-contamination, and thereby potentially save millions of dollars in new equipment and labor costs and reduce the time-to-market of critical medicines.

 
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