The power of GXP Shared Audits in the pharmaceutical industry

As GXP audits are mandatory requirements for pharmaceutical industry to safeguard safety and quality of medicinal drugs and products, APIs and excipients manufacturers have to undergo multiple GXP audits in a year for different buyers’ requirements. Over time, the industry has developed a system called ‘shared audit’ to cut down costs, time and resources for both sides of the supply chain.

Understanding Shared Audits for the pharmaceutical industry

Very much unique to the pharmaceutical industry, Shared Audits play a vital part in the quality assurance management around the world. It can be applied to all GXP audits, namely GMP, GLP, GCP, GDP and GVP.

As the name has suggested, Shared Audits refer to conducting more than one buyer’s audit requirement in a single GXP audit. So the supplier being audited will be able to accommodate multiple buyers’ requests within one audit, greatly reduce fatigue and duplicated effort from repeated audits. Normally, one Shared Audit consists of five to ten buyers’ and in some cases, a Shared Audit will hold as many as 25 buyers’ audit specifications.

The success of Shared Audits lies on the professionalism of the third-party audit firm. Below show how a Shared Audit is arranged once an audit is confirmed:

1. Identify potential partners. The audit firm will reach out to other pharmaceutical companies and gauge their interest in participating in shared audits. Aligning objectives and establishing a collaborative framework is crucial. It is important to note that consensus from audit site will be obtained for each shared request to ensure confidentiality is well-respected.
2. Standardize audit protocols. The the firm collaborate with partners to develop standardized audit protocols and evaluation criteria to ensure consistency and comparability of audit results.
3. Train auditors. Training will be made to auditors to ensure they are knowledgeable about the shared audit protocols, regulatory requirements, and industry best practices.
4. Engage suppliers. The firm also communicate the shared audit approach to our suppliers, emphasizing the benefits of streamlined processes, reduced audit fatigue, and opportunities for continuous improvement.
5. Conduct audit. On site, the audit team evaluates the supplier's facilities, processes, documentation, and compliance with relevant regulations and industry standards.
6. Deliver audit reports. Audit reports are prepared with the findings are shared with the participating companies according to their requirements, providing them a comprehensive and transparent view of the supplier and the product in scope.

This shared approach helps pharmaceutical companies maintain quality standards while reducing duplicate work, providing benefits that go beyond saving money.

Enourmous cost and resources efficiency

Shared Audits in pharmaceutical operations will optimize everyone’ resources significantly.

For the suppliers, when an upcoming audit is confirmed, they can invite other potential buyers to join the audit or appoint the audit firm to handle all communications and coordination. Most importantly, suppliers will only need to prepare for one audit internally, instead of handling audit multiple times in a year or in a month. The need to fulfill only one single audit assessment represents a substantial lower amount of manpower and time involved. Taking the normal Shared Audit cases mentioned in earlier paragraph, one Shared Audit of five or ten buyers means that the supplier is saving five or ten audit days.

On the other hand, buyers enjoy cost reduction directly from Shared Audits. Instead of commissioning a unique audit for themselves at full price, all buyers involved receive reduced rates so they will receive same high quality customized reports at lower costs. Such cost-saving is particularly crucial for smaller pharmaceutical companies with more cautious budget management.

For the whole supply chain, this Shared Audit approach drives positive environmental impact as well. Combining multiple individual audits into one reduces the footprint from travel.

Shared GMP audits help pharmaceutical companies excel in quality assurance while keeping costs budget friendly. These joint assessments save money through combined efforts, standard evaluation methods and simplified supplier relationships. Companies get complete quality system improvements and maintain strict compliance standards through experienced GMP auditors and well-laid-out evaluation processes.

Successful shared audits need careful planning, strong quality systems proper documentation and proactive customer service. Eurofins Healthcare Assurance is an ISO-9001 accredited audit firm to deliver Shared Audits worldwide. Check out upcoming audits available at https://h-aol.ai.eurofins.com/ and make Shared Audit booking with us anytime!