BioManufacturers Do More Supplier Auditing

Quality management is part of an increased focus on productivity and performance.

By Eric S. Langer, President, BioPlan Associates

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Auditing of suppliers is a universal practice among biomanufacturers. As the industry matures, however, we are seeing an increase in the amount and types of auditing being done, as a result of the industry’s increased focus on productivity and performance. In the 8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production [1], we found that almost half of biomanufacturers are auditing more of their suppliers and secondary suppliers (with nearly all presumably already auditing key vendors). 

We studied the quality management techniques being used by global biomanufacturers to assure quality of supply. Today’s evolving biopharma environment requires that biologics developers pay increasing attention to quality management issues to avoid production problems, capacity bottlenecks, and failures. An integral facet of this oversight is the supply chain: End-users are seeing more importance in supply chain management, and are increasingly attempting to take control through managing, assessing and protecting their supply of materials.

Our annual survey, with responses from 352 global biomanufacturers, asked respondents to identify what, in the past 12 months, their organization had done to assure consistent quality in raw materials and ingredient supply. Not far behind “audited more of our suppliers,” which was cited by 49% of respondents, was “audited our suppliers more frequently,” at 45% of respondents.

These numbers are not entirely unexpected—supply chain management and oversight are becoming more essential, particularly as the industry continues to adopt single-use/disposable bioprocessing equipment. Here, bioprocessing equipment is repeatedly purchased, used and disposed of, rather than being permanently installed and recycled. These repeated purchases place more stress and importance on the supply chain. Vendors and equipment suppliers (and, in turn, their materials, parts and component suppliers), must be in full compliance with regulatory and related documentation requirements. (See Figure 1.)

Bioplan
In addition to these data, our study shows that biomanufacturers:
-    Specifically identified secondary suppliers (e.g. those who supply our suppliers)
-    Implemented more dual-sourcing
-    Held more frequent meetings between quality staff and manufacturing staff
-    Manufactured some ingredients in-house

CMO Trends
We also compared biomanufacturers’ responses to contract manufacturing organizations, and found that CMOs, by nearly 10 percentage points, are more actively auditing their suppliers and secondary vendors (47% for biologics developers vs 56% for CMOs). They are also auditing suppliers more frequently (50% of CMOs vs 43% for biologics developers), and they are far more likely to test individual ingredients (44% for CMOs vs. 16%).

Biomanufacturers, however, are more active in demanding suppliers demonstrate higher levels of GMP (43.7% vs. 31.3% for CMOs). They are also more apt to develop new, more rigorous tests for incoming materials (34.5% for developers vs. 18.8% for CMOs). Communication tools are clearly preferred by biomanufacturers, with double the amount of biomanufacturers holding more frequent meetings or calls between quality staff compared to CMOs. (25.3% vs. 12.5%). According to Thomas E. Colonna, Biotech Consultant LLC and Associate Director of Regulatory Affairs at Johns Hopkins University, “Communication throughout the global manufacturing supply chain continues to be a key component in quality assurance” [1].

US vs. Western Europe Auditing
We compared U.S. and Western European responses to see how they differed in their approach. We found that U.S. respondents audited their suppliers more frequently than their Western European counterparts, by a considerable margin (55.7% to 37.5%). U.S. respondents also implemented significantly more comprehensive audits (52.5% for U.S. vs. 37.5% for W. Europe) and demanded suppliers demonstrate higher levels of GMP/GLP compliance (49.2% vs. 31.3%).

Strikingly, U.S. respondents were more likely to implement quality assurance measures almost across the board. The only areas that Western European respondents implemented at a greater rate than the U.S. were “manufacturing some ingredients in house” (21.9% for W. Europe vs. 6.6% U.S.) and “verified vendors’ Certificates of Analysis” (37.5% W. Europe vs. 34.4% U.S.). This may suggest that U.S. manufacturers employ audits of suppliers as their preferred method of assuring quality, while Western Europeans prefer less subcontracting in the manufacturing process as a method of assuring higher quality. It also may be due to audits simply being adopted more regularly as good business, in response to vendor-associated problems.

Vendors Blamed for Quality Problems
In addition, we evaluated seven key areas where respondents felt vendors have created quality problems. This year, making the top of the list of quality problems resulting from vendors, was vendors making promises they cannot keep (noted by 49.1% of respondents), poor product quality followed a close second, with poor service quality, inexperience with regulatory requirements, and inadequate certificates of analysis, record keeping or others (Figure 2).



Where vendors, particularly sales reps, make promises they cannot keep and/or provide defective or inadequate products, it can be presumed that their customers will seek out other vendors with more documented up-front product claims and better follow-through and quality products. To some extent, vendors not meeting their promises may be due to vendor-customer communication problems and customers taking in only the positive information supporting their purchase decisions. It is interesting to note that, when looking at the data compared to 2010, more respondents pointed to vendors making promises they could not keep, but less complained of poor product and service quality. Even though these latter issues appear to be on the decline, they continue to be key issues in need of attention.

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