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12 BioPharm International eBook June 2019 Single-Use Systems Supply Chain cleanroom. The production facility should have documented evidence of annual cleanroom recertifica- tion and a validated process show- ing a rotational cleaning regimen, as well as air/surface viable and nonviable particulate testing being carried out on a scheduled basis. Cleanrooms should also be mon- itored for real-time temperature, humidity, and differential pres- sure with alert criteria and defined actions in place to address issues. Product sterility validation The SUS supplier should follow a well-defined, recognized refer- ence standard identified by regu- lations, such as ANSI/A AMI/ISO 11137 (commonly referred to as VDmax25). VDmax25 relates to sterility, assuring that if a com- ponent (e.g., t ubing, bot t le, or system) is gamma irradiated to a minimum of 25 kGy, it has a ste- rility assurance level of 10 -6 (i.e., one chance in a million that a living organism would be found after the gamma process is per- formed). However, a single-point validation is insufficient. There should be documented evidence that revalidation is performed on a routine basis, as defined by the standard and the SUS supplier. Sterile barrier packaging valida- tion, which is different from ste- rility validation, can also be used to establish shelf life for an irradi- ated product. Lot release testing The supplier should be testing fin- ished products to verify that the produc t meets cer tain require- me nt s a f te r ste r i l i z at ion. L ot release testing has been driven b y d o w n s t r e a m a p p l i c a t i o n s after filtration. Most requests for this testing include United States Pharmacopeia (USP) <85> for bacte- rial endotoxins and USP <788> for particulate contamination. Quality documentation system A biopharma manufacturer should ensu re its suppl iers doc u ment their quality processes and systems and should see evidence that the documentation is being used on a regular basis. This is typically handled via onsite audits that take place at set intervals. Quality risk management (QRM) program Perhaps the most important way dr ug manufacturers can reduce r isk in t heir single -use supply chain is to make sure they under- stand a supplier's approach to qual- ity risk management. It is crucial for SUS suppliers to use a system- atic, documented process for the assessment, control, review, and communication of r isks to the qualit y of manufac t ured prod- ucts—these are key elements of cGMP manufacturing. A SUS supplier's QRM program should include the following: • A risk register, which is a senior- l e v e l m a n a g e m e nt e v a l u a - tion tool used to identify and review where the greatest risks may occur. This document can change over time as risks are identified and mitigated. • Quality metrics (e.g., on-time delivery, turnaround time for engineer's draw ings or qual- ity documentation, tracking of manufacturing defects) tracked on a regular basis for ongoing improvement. • A supplier quality management program that includes conducting risk-based audits of raw material suppliers in order to understand the quality management capa- bilities and processes of these companies. As a best practice, suppliers should develop a risk- based classification of suppliers; routine audits of high-risk suppli- ers would be performed. Quality agreements and performance reports would also be established to track suppliers in a measurable and actionable way. • An internal business continu- ity plan that includes a business Figure 2. A high-pressure single-use manifold is cleaned prior to packaging.

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