Getting, and Staying, Ahead of Global Quality Demands

As life-sciences companies expand the number of providers they work with around the world, it has become more difficult to maintain a high level of supply-chain integrity and supplier quality. Properly inspecting and qualifying supplier capabilities, integrating partners into product development, manufacturing, logistics, and service operations, and resolving supplier quality issues are among the challenges of today’s global supply-chain operations. When unchecked, these challenges can lead to contaminated products and subsequent recalls, financial losses, weakened brand value, and most importantly, risks to patient safety.

Companies that work with global partners often have visibility into only the first tier of their supply chain, while significant risks potentially hide deeper with sub-suppliers further downstream. Ultimately, the brand owner is responsible to ensure processes are in place to assure the control of outsourced activities and quality of purchased materials (1) and needs to take full ownership of managing suppliers (2).

Data integrity has become a chronic problem

In recent years, FDA has increasingly observed current good manufacturing practice (cGMP) violations at sites in developing countries, with many involving data integrity issues. “This is troubling,” reported FDA, “because ensuring data integrity is an important component of the industry’s responsibility to ensure the safety, efficacy, and quality of drugs” (3). Consequently, the Drug Quality and Security Act (DQSA) has set the timeline and metrics for demonstrating supply-chain integrity for the next decade.

In 2002, for example, FDA fined Schering-Plough $500 million for repeatedly failing plant inspections at four of the company’s manufacturing facilities. FDA inspectors found “significant violations of regulations related to facilities, manufacturing, quality assurance, equipment, laboratories, and labeling.” Due to these faulty processes, the company shipped medicine that contained little or no active ingredient, which led to as many as 17 deaths and several massive product recalls (1).

In March 2008, major recalls of the blood thinner, heparin, were announced due to contamination of raw material imported from China. At least 81 deaths were linked to the tainted substance. According to FDA, Baxter Pharmaceuticals failed to follow best practices to ensure supplier quality. The company did not monitor changes in the impurity profile of the incoming raw material, adequately investigate out-of-specification results, document processing steps in batch records, validate all critical steps in the process, qualify all suppliers, or use valid methods to test products (2).

In 2010, Genzyme agreed to correct quality violations at one of its manufacturing facilities and return $175 million in profits from the sale of products made at one of its plants. FDA inspectors found that the company’s systems for ensuring manufacturing quality were inadequate, which caused production delays, critical shortages, and drugs contaminated with metal, fiber, rubber, and glass particles (3).

As a result of some of these dramatic data integrity (4), quality, and compliance failures, there is heightened pressure and a significant opportunity for the industry to get ahead of quality demands, not only to meet regulatory requirements, but also to gain control over quality processes in this increasingly complex supply chain. In fact, half of respondents to a recent research study by LNS Research indicated that supplier quality management (SQM) is most crucial to a company’s success (5).

A shift in motivation is driving change

Historically, companies that do not encounter quality problems have not been motivated to change, advance, or optimize their quality systems and processes. However, more life-sciences companies are proactively re-evaluating quality management and implementing best practices and new technologies to better track quality processes, benchmark supplier performance, incorporate partners into quality processes, and manage global suppliers holistically.

In addition, a new FDA program will create even more incentive to make an ongoing investment in quality. FDA’s Office of Pharmaceutical Quality (OPQ) is planning to collect quality metrics “in advance of or in lieu of” an inspection to “develop [its] risk-based inspection scheduling.” This can “reduce the inspection frequency at an establishment” if a site shows robust metrics, allowing regulators to focus on companies that have quality issues (6). Today, technology is available to help companies stay ahead of their complex supply chain issues. One important change is the prevalence of cloud-based information technology platforms.

Whether they respond proactively or reactively, many life-sciences companies are making it a priority to change their outdated systems and processes to keep up with the pace of change. They have their work cut out for them.

While the supply chain landscape has become multifaceted and complex, the number of systems for managing quality has multiplied in silos. Companies inevitably struggle to maintain a holistic view of quality operations or understand how events are tied to upstream or downstream processes. As a result, a primary focus for many organizations is to unify their quality systems in an effort to more proactively manage risks with greater visibility across suppliers and ensure the ongoing, highest levels of quality. This is an area where cloud-based data management can help.

Transforming each stage of quality management

The opportunity for life sciences is to implement repeatable processes that incorporate global suppliers and more easily track performance at each stage of the global supply chain. With this type of visibility, organizations can ensure alignment, continually improve upon their approaches, and stay ahead of evolving quality demands. Summarized below are some best practices for each stage of the supplier quality management lifecycle:

• Streamlining supplier qualification. Supplier screening process can be complicated due to the wide spectrum of vendor profiles, including varying capabilities and levels of competency for each capability, countries they can operate in or import to, and the range of products and services they provide.  The same vendor that is providing outsourced clinical services could also offer small-scale manufacturing capabilities, as well as software and technology solutions.

• Using questionnaires to qualify potential suppliers can quickly rule out vendors that do not meet core requirements. Documents used in this process should be stored as controlled content within an integrated system so they can be quickly accessed and modified. A library of these documents should also be maintained and developed over time to allow continued fine-tuning of the screening process (and save time in the future). This process can ensure that companies concentrate only on strategically important suppliers, define clear targets, and measure performance against those targets.

• Auditing suppliers in real time. Vendors that pass the initial screening go through a detailed supplier audit that includes representatives from each relevant functional area. This audit evaluates all internal processes, procedures, and competencies for a supplier in providing the materials, services, and software needed to manufacture a safe, effective product. With a cloud-based system, audit responses are provided directly by the suppliers, electronically, enabling a more efficient exchange and retrieval of information. Providing transparency to all parties promotes alignment on supplier capabilities and a shared set of expectations. Performance metrics captured as part of the process including response times and number of cycles also helps to build out the supplier profile.

• Automating supplier onboarding. When a supplier is approved, the onboarding process takes place. The life-sciences company works toward alignment on the delivery of a product or service that includes the exchange of specifications, procedures, sampling processes, and acceptance criteria. Using a cloud-based application, these guidelines can be developed in-house, reviewed, approved, and shared electronically with vendors. Modern systems can automate the supplier onboarding process and enable vendors to confirm electronically that its internal resources have been trained in an organized, effective manner that is documented in the system in real-time.

• Using risk to oversee suppliers. Without the right technology, companies must use manual methods to oversee and monitor suppliers, which makes it impossible to manage them in real-time. Furthermore, companies often spread their oversight effort too thinly, leaving just enough resources for firefighting, and responding to day-to-day operational incidents, rather than taking the proactive and preventative actions that drive deeper upstream improvements.

When ongoing oversight is conducted in a cloud-based system, quality metrics can be linked directly to suppliers. These metrics come from a single source that has incorporated suppliers into the process--providing, early on, clear indication of emerging quality issues.

Quality indicators, based on historical and current performance, can be aggregated to form a supplier risk profile, driving prioritization of resource allocation. This helps to ensure the quality team focuses on vendors that pose the greatest risk to product quality.

Holistic supplier quality: bringing it all together

Paramount to supplier oversight is the ability to obtain and maintain accurate, real-time quality data and automatically incorporate that information into operations for quality management. Modern technology, accessible by all stakeholders in the cloud, can enable real-time information sharing and process integration. Supplier quality performance information can also be aggregated, to get a holistic view, and compared across vendors to identify ones with the greatest risk. With more complete and real-time information, life-sciences companies are able to identify and address areas of potential quality issues before they result in a large-scale catastrophic occurrence.

Cloud-based technology can provide all stakeholders--including suppliers, contract manufacturers, and contract labs--with accurate, real-time quality control data in a single, integrated system. Cloud applications can, for example, automate supplier qualification so that data obtained in the qualifying process can be used to monitor the supplier on an ongoing basis.

Additionally, a cloud-based system can allow companies to track quality problems with vendors over time. Because the integrated system automatically links the issues to that supplier, the company can view one source for all information about the supplier. The system also allows a company to benchmark the performance of suppliers, one against the other, to determine the suppliers that are most effective in terms of quality.

Further, only an integrated cloud-based system has the unique capability of bringing supplier and quality information together in one place. The supplier information becomes a continuous growing permanent record for an increasingly better understanding of supplier performance and ensuring more accurate vendor comparisons to make prudent choices.

Cloud technology is an asset that life-sciences companies can leverage to overcome the challenges of collaborating with global suppliers. A cloud system integrates and streamlines operations, and enables adherence to regulatory standards for supply-chain integrity and supplier quality.

References

1. FDA, Guidance for Industry, Pharmaceutical Quality Systems, Section 2.7, Management of Outsourced Activities and Purchased Materials, FDA.gov.
2. P. Patel et al., “Four Steps to Managing Supplier Quality,” PharmaManufacturing.com, Sept. 12, 2012.
3. “Genzyme to Give Up $175 M in Profits Under Consent Decree to Rectify Issues at Production Plant,” Genetic Engineering & Biotechnology News, May 25, 2010.
4. FDA, Guidance for Industry, Data Integrity and Compliance with CGMP, Draft Guidance (CDER, April 2016), fda.gov.
5. “Supplier Quality Management: SQM’s Rightful Role in Our Enterprise,” LNS Research, 2016.

Article Details

Pharmaceutical Technology
Vol. 41, No. 2
Supplement
February 2017
Pages: s28-s30

Citation

When referring to this article, please cite it as M. Jovanis, “Getting, and Staying, Ahead of Global Quality Demands," Supplement to Pharmaceutical Technology 41 (2) February 2017.