Pharma supply chain management: questions to ask an audit partner - Part 2

11 Feb 2025

Future proofing your organisation’s focus on quality

In today's globalized pharmaceutical industry, an audit partner's network of qualified auditors and long-term vision are vital to effective pharma supply chain management, ensuring your organization's commitment to continuous quality improvement. Evaluating the global presence of these auditors is essential for a seamless audit process, and choosing the right partner to support your future growth is a critical consideration when selecting an audit provider.

Does the partner's network of qualified auditors have a global reach?

The global reach of pharmaceutical supply chains requires a network of auditors in different parts of the world. An audit partner with a network of qualified auditors strategically located around the world guarantees appropriate accessibility and expertise at different supplier sites. 

It is essential to know the number and location of the partner's auditors. For example, if many suppliers are located in Asia, but the partner's auditors are based solely in Europe, logistical problems are bound to arise. In addition, language barriers may prevent effective communication, as auditors may have difficulty using documents written in the local language or conversing with suppliers in their native language. It is therefore imperative to use local auditors wherever possible to improve audit efficiency.

Effective audits depend on auditors possessing the qualifications, independence and language skills required to ensure complete, fair and impartial assessments. It is essential to have an overview of an auditor's qualifications, usually provided by their CV, to ensure both technical and auditing competence. In addition, the auditor's independence is paramount, requiring no affiliation with the suppliers under review. A code of ethics signed by auditors reaffirms their commitment to impartiality and independence, ensuring that audit results are based solely on observed findings.

An audit partner's experience with various types of suppliers is advantageous, as it inspires confidence in their ability to effectively manage the complexities of different supply chain environments. This extensive experience strengthens the audit partner's ability to align the scope of the audit with the most relevant standard, adapting methodologies and approaches to take account of the specific environment of different suppliers, ultimately leading to more reliable and relevant audit results.

Does the audit partner have a long-term vision?

It's important to work with an audit partner who has a future-focused approach. A competent audit partner should actively help its customers to complete their audit programme. This means inviting them to participate in relevant shared audits and anticipating their audit needs based on the partner's track record and integration of newly required information into audit reports. A competent partner should help to address all potential obstacles that present a challenge to a client successfully completing their audit programme.

It is imperative that the audit partner has a strong team of qualified available auditors, facilitating travel to supplier sites for audits. In addition, it must contribute to the customer's quality assurance efforts and support its continuous improvement initiatives, to ensure that quality standards are constantly reinforced year after year.

A regular exchange between the audit partner and its customer is essential, the frequency being dictated by the volume of the audit program, the scope of the audits carried out and by the customer's specific needs. Seamless communication is essential, facilitating smooth follow-up and discussions to address emerging issues or opportunities for improvement.

Environmental sustainability and impact of travelling for audits must be considered in all future audit processes. This impact can be reduced by using local auditors located as close as possible to sites, and also by using shared audit solutions. Shared audits offer an excellent opportunity to reduce travel-related carbon emissions, enabling sustainability objectives to be met without impacting audit results. When selecting an audit provider, it is essential to also consider their commitment to environmentally friendly practices and their willingness to adopt innovative audit approaches that prioritize sustainability.

In conclusion, selecting the right audit partner with a global network of qualified auditors and a long-term vision is essential for supporting your organization's growth and commitment to quality. The partner's ability to provide localized expertise, ensure auditor independence, and embrace sustainability in audit practices is crucial to conducting effective audits and fostering continuous improvement. By carefully evaluating these factors, you can choose an audit partner that aligns with your strategic goals and contributes to your success in the global pharmaceutical industry.

More on our pharma audit services:

Find out more about our audit solutions for healthcare supply chain quality. This includes our confidential shared audit approach and shared audit system which gives a real-time view of Intertek's forthcoming scheduled GXP shared audits of manufacturers and distributors. For more information visit our shared audit online: https://www.intertek.com/pharmaceutical/auditing