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What are the best practices for conducting quality audits of your contract manufacturer?

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Quality audits are essential for ensuring that your contract manufacturer (CM) meets your expectations and standards. They help you monitor the performance, compliance, and improvement of your CM, as well as identify and mitigate any risks or issues. However, conducting quality audits of your CM can be challenging, especially if you have multiple CMs, different locations, or complex products. In this article, we will share some of the best practices for conducting quality audits of your CM, based on our experience and expertise in contract manufacturing.

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Lance Harding
Atishay Jatia

Director - Renown Pharmaceuticals - Contract Soft Gelatin Capsules Manufacturer |?25+ Countries | 300+ Products | 150+…

1 Define your audit objectives and scope

Before you start your audit, you need to define your audit objectives and scope. What are the main goals and outcomes of your audit? What are the specific areas or processes that you want to evaluate? How often and how long will you conduct your audit? These questions will help you plan your audit strategy, allocate your resources, and communicate your expectations to your CM. You should also review your contract and quality agreement with your CM, and make sure that they align with your audit objectives and scope.

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Atishay Jatia

Director - Renown Pharmaceuticals - Contract Soft Gelatin Capsules Manufacturer |?25+ Countries | 300+ Products | 150+ Customers |?200+ Employees | 10+ Years in this field
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After serving 100+ clients, I can give some points on this. Mostly our clients follow below steps A. Before the Audit: - Prioritize Audits - Plan and Scope - Review Contract & Regulations - Gather Documents B. During the Audit - Qualified Auditors - Structured Approach - Observe and Interview - Review Records C. After the Audit - Findings Report - Corrective Action Plan - Follow Up

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Lance Harding
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It is best to have an agreed upon standard for the audit, such as specific regulatory requirements, industry standards, best practices, or your own inspection protocol that have been shared in advance with the CM.

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2 Choose the right audit team and method

The next step is to choose the right audit team and method for your audit. Depending on your audit objectives and scope, you may need different skills and expertise in your audit team. For example, you may need technical, regulatory, or operational auditors, or a combination of them. You should also consider the qualifications, experience, and independence of your auditors, and provide them with adequate training and support. Additionally, you should decide on the best audit method for your audit, such as on-site, remote, or hybrid. Each method has its own advantages and disadvantages, depending on your audit objectives and scope, as well as the availability and cooperation of your CM.

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3 Prepare and execute your audit plan

Once you have your audit team and method, you need to prepare and execute your audit plan. Your audit plan should include the audit schedule, agenda, checklist, criteria, and tools that you will use during your audit. You should also inform your CM about your audit plan, and request any relevant documents or information that you may need before or during your audit. During your audit, you should follow your audit plan, but also be flexible and adaptable to any changes or issues that may arise. You should also document your audit findings, observations, and recommendations, and communicate them clearly and objectively to your CM.

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Lance Harding
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In person audits need to be sure to cover both reviewing documents as well as time out in the facility observing the operation. Audit observations should be brought up to the auditee as they are found, and briefly summarized at the end of each day, briefly stating what was deficient with reference to the specific part of the standard. The auditee should have a chance to ask questions, and to provide additional evidence if they don't agree with the observation. You should have a closing meeting scheduled at the end of the audit, where all the observations can be briefly reviewed with CM host team and their management.

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4 Follow up and close your audit

The final step is to follow up and close your audit. You should prepare and submit your audit report to your CM, and request their response and corrective actions within a reasonable timeframe. You should also monitor and verify the implementation and effectiveness of the corrective actions, and provide feedback and guidance to your CM. You should also evaluate your own audit performance, and identify any areas for improvement or learning. Finally, you should close your audit, and update your audit records and status.

Quality audits are a vital part of contract manufacturing quality control. By following these best practices, you can conduct quality audits of your CM more efficiently and effectively, and ensure that your CM delivers high-quality products and services that meet your requirements and expectations.

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Lance Harding
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If not already closed by the time of the response, the CM should include the responsible person, and the due dates for the completion of each CAPA. Critical findings must receive urgent attention. Major and minor findings can have reasonable completion timelines, especially if data must be gathered or equipment repaired/replaced. Recommendations can be made in the audit report, but responses are not typically required from the CM for these.

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5 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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What are the best practices for conducting quality audits of your contract manufacturer?

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1 Define your audit objectives and scope

2 Choose the right audit team and method

3 Prepare and execute your audit plan

4 Follow up and close your audit

5 Here’s what else to consider

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