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VIRTUAL SUMMIT: PharmaEd Resources Cleaning Validation Summit
February 10, 2021 @ 8:00 am - February 11, 2021 @ 5:00 pm
Can you implement the best science-based, risk-based, and statistics-based approaches for cleaning validation? Today’s regulators are now expecting ADE monographs and risk assessments of your organization’s cleaning validation programs.
Implementing a Risk-Based, Data Integrity Compliant Cleaning Validation Management System
Sheba Zaman, Head of Product Specialists at Novatek International
In pharmaceutical manufacturing, risk of contamination is from a broad range of factors such as cross contamination (other pharmaceutical active ingredients), cleaning agents and micro-organisms. Additionally, the risk of contamination may in some cases be from a calculation error which results in choosing the
wrong Maximum Carry-Over Limit (MAC). For example, can you consider the number of calculations required for an equipment train, with twenty (20) sample points, having different surface areas (swab sample area), different sampling types (swab/rinse), five (5) products manufactured on the equipment train, and each product has ten (10) production stages, and two (2) different cleaning agents are used. There is a huge risk associate with calculating the Maximum Carry Over Limit (MAC) manually.
Automation has played a key role in decreasing risks associated with various processes. Data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of pharmaceutical products.