Quality Management: How Much Are Vendors To Blame?

By Eric Langer, President and Managing Partner, BioPlan Associates, Inc.

Biopharmaceutical manufacturing is one of the most demanding industries on its suppliers: demanding that its vendors be prequalified as primary or secondary, requiring confirmations of product provenance, certificates of analysis, and other sometimes onerous documentation. All of this is done for drug product quality and consistency. So it comes as no surprise that quality managers are continuing to take a close look at their vendors. Our 11th annual biopharmaceutical manufacturing industry report indicates that companies are vetting suppliers more closely than ever, demanding even higher levels of GMP/ GLP compliance (see: "Who's Improving Bioprocessing in 2014?" in our January 2014 issue). In our current industry study — 11th Annual Report and Survey of Biopharmaceutical Manufacturers — we review quality problems attributed to vendors, finding that half of our biopharmaceutical company participants complain of a variety of problems initiated by their vendors, from change notification problems, where they didn't notify clients of changes, to regulatory inexperience.

8 IN 10 SUPPLIERS HAVE CREATED QUALITY PROBLEMS
Results from the study indicate that the vast majority of industry decision makers attribute at least some quality problems to their vendors. Overall, only 18 percent of respondents said that vendors have not created quality problems for them and that they are generally satisfied with their vendors in this regard.

The most common complaint in this highly regulated environment relates to suppliers not informing customers of changes, with half of the respondents frustrated by the problems suppliers create in this regard. In addition, 43 percent of respondents note that, overall, vendor change control is poor.

The high rate of problems due to poor vendor change control and poor product quality are troublesome because these factors potentially lead to batch failures and/or regulatory compliance issues for the biopharmaceutical manufacturer. It is, therefore, critical for manufacturers to develop stronger relationships with their vendors and to maintain quality agreements with specific requirements.

Clearly, change control is a quality problem plaguing the industry, but there are other issues, too (see figure 1). Other complaints cited by at least one-quarter of the industry include include poor service quality and poor product quality.

SIGNS OF VENDOR IMPROVEMENT
There are reasons to believe that vendors are improving, though. For example, the 18 percent of respondents this year saying they have not experienced any quality problems traced to vendors is a step up from nearly 16 percent last year. And on some of the quality issues identified, fewer participants are seeing problems this year.

That's particularly the case when it comes to the inadequacy of certificates of analysis for products. This year, fewer than one in five said that vendors had created problems for them in this area, down from roughly one-quarter of participants in the prior three years of surveys and roughly one-third of respondents in the three years prior to that.

Also this year, just 7 percent complained of vendors not filing a Device Master File on their product. That marks a new low for this issue, which has remained above 10 percent during most of the previous six years of surveys.

SERVICE PROBLEMS NOW OUTWEIGH QUALITY ISSUES
Interestingly, issues of product and service quality are moving in opposite directions this year. In a reversal of trends we observed in recent years, our latest report shows that vendors may be getting better at producing their products and services, but getting worse in delivering their products and services.

This year, 28 percent of respondents identified poor product quality as causing problems, down from 39 percent last year. In fact, this year's results are a sizable improvement from years past, in which as many as 45 percent of participants had cited product quality problems.

Instead, for the first time, we found more respondents complaining of poor quality service (29 percent) than poor quality products (28 percent). The uptick in service complaints came from about one-quarter of participants noting service quality problems in each of the past two years.

VENDORS STILL OVERPROMISE
Over a third (38 percent) of biomanufacturers are concerned that vendors continue to make promises they can't keep. And while this problem isn't unique to the biopharma industry, it becomes far more critical because the FDA and EMA are involved. Biopharma companies realize that their reputations and even their existence could be undone if suppliers don't provide what they say. This figure has hovered around this level each year since 2008. So the problem seems to be somewhat ingrained.

When vendors — particularly sales reps — make promises they or their companies cannot keep (and/or provide defective or inadequate products), it can be presumed that their customers will seek out other vendors with better, more documented products and better followthrough. However, qualifying a new vendor can be arduous, and most companies prefer to avoid switching.

To some extent, when vendors don't meet their promises, it may be due to vendor-customer communication problems and customers not "hearing" negative information concerning their purchase. Also, end users may not be asking the right questions or requesting all the available documentation regarding their bioprocessing equipment, materials, and supply chain — and vendors may not be routinely providing this info.

Also, end users may not be asking the right questions or requesting all the documentation available regarding bioprocessing equipment and their materials manufacturing and supply chain, and/or vendors are not providing it.

QUALITY AGREEMENTS ARE CRITICAL
One of the challenges faced by biopharmaceutical manufacturers is that, due to regulatory demands, it is often difficult to change vendors for key materials. For this reason, manufacturers must continue relationships with vendors even when there is a high degree of dissatisfaction with various aspects of the material or service provided.

In order for manufacturers to build confidence in their relationships, they must have solid quality agreements with suppliers and perform regular audits to be certain that both parties have a clear understanding of exactly what is expected. One of the biggest issues with vendors is managing their own unanticipated manufacturing changes. Vendors' raw materials suppliers may not be communicating up the chain in a timely way to either the manufacturer or the equipment users. In some cases, vendors do not realize that a change has been made by their supplier until long after the fact. This creates problems that some attribute to lack of communication. Solid quality agreements can help reduce these problems for client companies and build confidence into their relationships.

Survey Methodology: The BioPlan annual survey of biopharmaceutical manufacturers yields a composite view and trend analysis from over 300 responsible individuals at biopharmaceutical manufacturers and CMOs in 29 countries. The survey included over 150 direct suppliers of materials, services, and equipment to this industry. This year's study covers such issues as new product needs, facility budget changes, current capacity, future capacity constraints, expansions, use of disposables, budgets in disposables, trends in downstream purifi cation, quality management and control, hiring issues, and employment. The quantitative trend analysis provides details and comparisons of production by biotherapeutic developers and CMOs. It also evaluates trends over time and assesses differences in the world's major markets in the U.S. and Europe.