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Do Internal Audits Focus on Agency Regulations and Compliance Items or Do They Focus on Other Things Too?

With internal audits you want to audit to particular regulations. If you are under International Organization for Standardization (ISO) or Good Manufacturing Practices (GMP) constraints you want to make sure you are touching on any regulatory or compliance issues that a costumer, the Food and Drug Administration (FDA), or any other international agency is going to look at. That being said, it is also very important to concentrate on other areas as well as it comes down to best practices. You should look at your controls in place for everything from training records to manufacturing plans to organization and how you manage inventory. Concentrate on the regulatory compliance but be sure to include every area in your internal audit. If there are other areas that you feel are non-compliant, it is still important to audit concentrating on those areas as a best practice.

Internal audits are extremely useful and can be a very effective management tool when done properly. Some companies don’t do them thinking that a customer audit is interchangeable with an internal audit. This is not the case because customer audits are focused on a particular process line or product. With an internal audit you need to cover your entire organization and process line.

We recommend and use the FDA Q 10 approach when you are doing audits of your key systems, lab system, quality system, or manufacturing system. That’s the approach the FDA uses as well. The FDA Q 10 is the most effective approach for getting the maximum value out of your audit.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.


  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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