So, you have received a request for a supplier qualification audit; great!  This has probably been the culmination of months of discussions and negotiations by your business development teams to get to a proposed contract stage and ready for qualification.

The process of evaluating the quality and compliance of your company as a supplier or subcontractor that provides products or services to the new pharmaceutical customer is a pharmaceutical customer audit. Typically, the quality assurance unit of the new pharmaceutical customer or an external auditor hired by them conducts these audits. Depending on the contract and the risk level of the supplier or subcontractor, customer audits can be very in-depth multi-day team audits through to single-day and even partial days with some level of remote assessment for lower-risk activities.

Completing a customer audit is vital for the customer to ensure that your company, as the supplier or subcontractor, meets the pharmaceutical company’s specifications, requirements, and relevant regulations and standards. These audits can also highlight potential risks, best practices, and areas that need improvement.

Audit inspection room

Getting ready for a customer audit can be difficult, particularly when it’s unexpected or with little notice. Nonetheless, by organising and getting ready appropriately, you can effectively pass a customer audit and display your dedication to quality and compliance. In this article, I explore some of the steps to follow for getting ready for a customer audit.

It is common enough for the audit host team to feel some anxiety during the auditing process. However, it’s essential to take a moment to breathe, ground everyone and remember that auditors usually aren’t trying to catch you out. Their goal is to ensure that you have what it takes to make their products and adhere to regulations to complete the subcontracted work.

Step 1: Understand the scope and who is auditing you.

The first step in preparing for a customer audit is to understand the scope and purpose of the audit. The audit scope defines what aspects of the supplier’s or subcontractor’s operations and processes will be audited.

It’s essential for the customer to clearly communicate the scope and purpose of the audit to their supplier or subcontractor beforehand, ideally in writing. You should then thoroughly review and understand the scope and purpose of the audit and ask the customer any questions or seek clarification if needed before the audit.  Find out the auditor’s name and reach out within the organisation to determine if anyone has been audited by them before. It’s a good idea to find out if the auditor has any specific areas of expertise as it can help to know what areas will need to be well prepared and if there might be any weaknesses going into the audit.

Step 2: Plan for the audit

Next, you should assign roles and responsibilities for the customer audit, including designating a person or team to coordinate and manage audit activities. It is important to ensure that everyone participating in the audit is fully informed of their duties and obligations, as well as the objectives and parameters of the audit. Additionally, it is best practice to offer appropriate education and guidance to staff on communicating professionally and efficiently with the auditor.

Step 3: Collect and review the documents requested.

The third step to prepare for a customer audit is to carefully review all requested documents and records to ensure they are ready for auditing. It’s essential to ensure that all relevant documents and records are accurate, complete, up-to-date, consistent, easily accessible, and compliant with regulations and standards. The auditor may request documents and records, including the Quality Manual, Site Master File, Procedures, validation reports, non-conformances, CAPA records, risk assessments, and batch records.

Before handing over any documents or records to the auditor, it is essential to review them thoroughly and ensure they are approved by authorised personnel. Any changes made should be documented with justification, and all deviations must be investigated with a robust root cause analysis. Corrections should be implemented with proper verification, and corrective actions must be completed with an evaluation of their effectiveness. If suppliers or subcontractors play a crucial role for the potential customer, it will be necessary to ensure all suppliers have been adequately qualified and that appropriate agreements are in place.

Step 4: Create an atmosphere of integrity and Professionalism on the day.

It’s crucial to make an excellent first impression, and it’s equally important to have senior management present during the opening and closing meetings to reinforce your company’s dedication to the end product’s quality, safety and efficacy. Additionally, don’t forget to prepare anyone interacting with the auditor to prepare them for any questions that the auditor may ask.

When the auditors visit your facility, they will almost certainly want to meet the team responsible for the work. They will also review the training files and may wish to speak with the trainee. If your team can confidently and comfortably communicate with the auditor, it will reflect positively on the company.

During the audit, it is best to be honest if you or another team member are unsure of an answer. It is easy to detect when someone is trying to conceal their lack of knowledge. Inform the auditor that you are unsure and require advice from the Subject Matter Experts (SMEs) before responding. In most cases, they are understanding and will provide sufficient time for you to give a response.

mock inspection training

Step 5: Be ready at the close-out meeting.

When undergoing an audit, you will likely receive findings from the auditor. It is a rare occurrence to have no findings at all.  It is important to note that each auditor may have their own interpretation of the same regulations, which could result in varying recommendations from audit to audit. If you feel that a finding is not in line with the regulations and you are compliant, it is appropriate to voice your interpretation and push back.  However, you MUST remain professional and courteous and be prepared to see both sides if the auditor goes on to explain their interpretation of the regulations.  Remember, this is a customer you are trying to build a long-term relationship with, and you may need to assess whether it is worth getting into an argument if the potential CAPA will not place an undue burden.  Likewise, the customer will respect your knowledge and competence if your pushback is justified, and it isn’t unheard of for auditors to see the auditee’s point of view (where justified).

Step 6: Promptly follow up with Robust CAPAs where required.

If you receive major findings, it may not be the end of the world. Treat it proactively as an opportunity for improvement, and be prepared to discuss how to resolve the problem. Follow up with any immediate CAPA plans and leave the auditor with an understanding that you will rectify the issue.

A CAPA plan is a concise document describing how you will address and resolve any nonconformities or deficiencies identified during the customer audit. A corrective action plan should include the following elements:

    • The description of the non-conformity or deficiency;
    • The determined root cause of the non-conformity or deficiency;
    • The corrective action to be taken to eliminate the non-conformity or deficiency;
    • The preventive action to be taken to prevent the recurrence of the nonconformity or deficiency;
    • The responsible person or team for implementing the corrective action and preventive action;
    • The target date for completing the corrective action and preventive action.

You should prepare the corrective action plan as soon as possible after receiving the customer audit report, preferably within a week or two at the most. You should also present the corrective action plan to the customer and the auditor for review and approval and follow up with them until all nonconformities or deficiencies are closed.

Maintaining clear communication and adhering to action plans demonstrates your proactive approach and proficiency in resolving issues promptly and competently. This, in turn, instils confidence in the auditor and assures your client that their decision to approve your facility is well-founded.

Preparing for a pharmaceutical customer audit is crucial for ensuring quality and compliance in the industry. By following these steps, you can effectively and efficiently demonstrate your capability and reliability to the customer and improve their satisfaction. A successful audit can also increase business opportunities and enhance your reputation.

At Orion Consulting, we can assist with preparing for that critical customer audit.  We have a team of GXP audit professionals with experience managing bespoke audit requirements to assess technology transfer capabilities and manufacturing technologies or to conduct an initial assessment or mock inspection of sites to GMP, GLP, GCP and GDP regulations.

We have assisted many clients in getting ready for qualification audits, and we can review the company readiness and assist during and after the audit with document preparation and CAPA planning.

If you need immediate assistance or have a critical or urgent audit that you need to prepare for then, please get in touch with us at: or phone +353 (0)7198 10101