Auditing and Testing in the Global Pharmaceutical Supply Chain

Auditing and Testing in the Global Pharmaceutical Supply Chain

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Auditing your suppliers is a key part of your quality and compliance improvement. A pharmaceutical company needs to insist on a confidential, in-depth audit of every part of the facility, operations, and quality systems relating to the materials it wants to purchase, including manufacturing and testing details.

In addition to regular, thorough manufacturing facility audits, the company should actively ensure that it or its brokers have reliable, up-to-date knowledge and verification of the drug substance upstream to ensure that materials really do come from approved sources.

Weighing Cost Savings Versus Risk

The one-time mantra ‘Faster, Cheaper, and Better” is no longer a differentiator as suppliers and contract services have become commoditized in today’s global economy. The reality is that if manufacturing and supply chain integrity cannot be verified regularly, the initial cost savings from a cheap source cannot compensate for increased risk. Companies need to determine the frequency and extent of re-evaluation of suppliers. Risk-based measurements should be determined for data analysis in reviewing suppliers, including:

  • assuring meaningful data is captured;
  • configuring data such that problems can be identified; and,
  • identifying data-driven status changes.

Supplier audits must be performed by skilled, experienced auditors who are technical experts, and preferably fluent in the local language. Auditors must be granted sufficient time to look carefully at the supplier’s operations and records.

Tackling Supply Chain Complexity

In 2008, sales of the blood thinner Heparin were halted following about 350 reports of health problems associated with the drug. About 40 percent of those were deemed ‘serious.’ It was later determined that the potentially toxic Heparin was produced in a Chinese factory that was never properly inspected by the FDA. The now infamous Heparin problem exposed the complexity of a multi-tiered and global supply chain. While companies may be less concerned with their supplier’s suppliers, when it comes to business risk, this visibility becomes essential.

With the complexity of the supply chain – geographic locations, numerous partners – industry developed a consortium approach to audit execution and information collaboration. Ten years ago, following the Heparin Scare, industry developed a consortium approach to audit execution and information collaboration. Rx-360, a non-profit international pharmaceutical supply-chain consortium, was established with the sole purpose of securing the supply chain that effects patients, therapies, and public safety. Everyone involved rallied and worked together as an industry to look at gaps in the supply chain, benchmark against each other, and implement best practices.

A decade later, Rx-360 continues to seek efficient and effective approaches to supplier risk management, combining the efforts of leading pharmaceutical companies to implement audit standards, auditor training, and auditor certification.

Auditing for Potential Supplier Risks

To ensure that product quality is maintained, there must be a risk management process that covers the entire lifecycle. This requires strong supporting pharmaceutical audit processes, and an improved quality of internal and 3rd-party audit resources and information management systems that allow in-company resources and external supply chain partners and auditors to share information.

The risk assessment process needs to include an execution of pre-qualification processes for new suppliers and accompanying follow-up audits. Given the limited resources available for numerous audits, a risk-based approach is essential.

In addition, the issue of visibility of the supply chain has become a key issue. The infamous Heparin problem exposed the complexity of a multi-tiered and global supply chain. While companies may be less concerned with their supplier’s suppliers, when it comes to business risk this visibility becomes essential. The importance of risk-based inspections and materials testing cannot be overs-stated.

Managing Efficient and Effective Supplier Inspections

Traditionally, manufacturers get inspection records for raw ingredients once the material physically arrives at their premises. A good inspection system will allow for creation of different types of sampling plans,  Acceptable Quality Level (AQL), and other characteristics, outlining the criteria to inspect supplied materials. The receiving inspection system, through inspection capabilities and based on inspection results, allows companies to prevent out-of-spec supplied materials from entering the production environment.

However, even if the tests are made more specific, the risk of contamination for materials can be significant. Sometimes, even 3rd-party testing is not enough to assure the quality of pharmaceuticals. It is not possible to test quality into a pharmaceutical product because good quality must be built into the product by using appropriate materials and validated processes to ensure the product’s safety and efficacy. There is a risk that modification of even a single processing step can change the by-products or impurities of event materials. As with a final drug substance or API, testing is a confirmation of a material’s quality, but may not be enough on its own without manufacturing records demonstrating that each batch was made according to a validated process and complied with the final product specifications.

Complying with Industry Regulations

Given the vast transparency of the data and analytics tools that federal regulators now have at their disposal, it’s prudent for pharmaceutical manufacturers to consider developing their own advanced capabilities in these areas or to partner with a GMP-experienced organization to develop them. This move enables companies to proactively identify and mitigate potential compliance problems before regulators take formal action—an approach that regulators don’t just encourage but expect.

Securing a trusted partner for contract audit services can be beneficial, for a host of reasons, to tempering potential supply chain risk. IQVIA’s quality and compliance auditors, for example, provide a 3rd-party assessment following the latest industry standards and industry benchmarking, covering all geographical needs. Services include advanced identification of potential issues, provision of a virtual QA department when additional resources are needed, regulatory and industry expertise, and extensive auditing experience.

The best suppliers will accept this new reality of increased transparency, and brokers and distributors who can establish and guarantee the level of quality assurance associated with more rigorous auditing and supply chain verification will be invaluable.

SmartSolve® Supplier Management

Companies need to develop, implement, and maintain a supplier management program that integrates compliance, oversight, and strong supplier relationships into business practices and quality systems.

IQVIA SmartSolve QMS provides support for the processes integral to a compliant and successful supplier quality management program. With an eco-system of supplier quality modules, IQVIA empowers organizations to evaluate, track, report on, and rate suppliers to tackle the challenges presented by a complex supply chain.

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Kari Miller

Regulatory & Product Management Leader, IQVIA Quality Compliance