What Preparation You Need to Be Ready for the DSCSA Audit

WHAT IS A DSCSA AUDIT?

The Drug Supply Chain Security Act (DSCSA) is nearing the end of its 10-year implementation period. It has already bought massive changes in the pharma supply chain operations with the introduction of mandatory serialization and track & trace requirements.

But as the last phase approaches, companies will have to make sure they’re compliant with all the final stage interoperability and aggregation requirements, and be ready for the DSCSA audit.

What is it? Well, to ensure that the entire industry is ready for compliance. From questions related to the specific requirements to an end-to-end inspection of the technology, you can expect a wide range of examinations during a DSCSA audit.

So, let’s see where the pharmaceutical industry currently stands in terms of compliance and what steps you can take to get ready for the imminent DSCSA audit.

THE READINESS OF PHARMA MANUFACTURERS

Imagine FDA showing up at your manufacturing centre for an audit. You have ensured that your team is well-versed with the nitty-gritty of the guidelines and are ready to show proof of your track and trace system. But out of nowhere, they ask you to demonstrate data sharing with downstream trading partners and verification of data received from above. And unfortunately, you aren’t prepared for a full-fledged demonstration.

This may give the officials an impression of non-compliance, which can hurt your enterprise’s reputation.

Moreover, data sharing and verification isn’t all there is to DSCSA. Supply chain members have to comply with over 60 requirements, with manufacturers facing a bulk of these guidelines.

Usually, manufacturers and quality assurance teams deal with auditors. However, the FDA audit is going to be a bit different and may require your company personnel to know every small detail regarding the guidelines. Sadly, manufacturing and quality assurance teams are rarely subject-matter experts. That’s why it’s necessary to include your organization’s internal management team as well prior to the audit.

For a successful audit:

Your associates must know which teams to involve during the inspection
Your team members must understand their role under DSCSA
Your business must also understand these needs inside out

More than everything, you should be ready to demonstrate data reporting, data verification, and track & trace capability on an end-to-end electronic system. Let’s explore the ways you can get ready for the DSCSA audit.

Note that the FDA recently granted exemption for connected trading partners only, setting a new deadline for manufacturers and repackagers: May 27, 2025.

Steps to Take

GET FAMILIAR WITH THE LAW

To avoid any surprise questions when the FDA finally arrives on your doorstep, it’s best to get familiar with all facets of the law. Get comfortable with all the various requirements outlined in the law, along with their respective deadlines. Also, the FDA has issued different guidelines for different supply chain members.

Make sure you understand the specific guidelines required of your organization, along with knowing all the other general supply chain guidelines. If possible, you can also conduct a training session for the other employees so no one is caught off-guard during the audit.

MOCK AUDITS

Just knowing all the requirements won’t prepare you for the real thing. Conducting mock audits, on the other hand, can help you get used to the feel of the audit. Not only will it help you get accustomed to the pressure, but it will also allow you to identify and rectify any gaps in your track & trace and data-sharing system, and in your documentation.

LEARN HOW TO REPORT ILLEGITIMATE OR SUSPECT PRODUCTS

Since the whole law is about preventing the entry of fake drugs into the pharma supply chain, it’s imperative you know how to handle the situation if you do encounter an illegitimate product. Fortunately, FDA has laid out the reporting guidelines you need to follow.

The requirements specify that companies must:

Investigate and quarantine any suspect products and determine whether they are illegitimate or not
If the product is in fact counterfeit, companies must notify the FDA and the immediate trading partners.

This requirement applies to all authorized trading partners – manufacturers, repackagers, dispensers (pharmacies), and wholesale distributors.

CONFIRM THAT YOU’RE TRADING WITH AN AUTHORIZED PARTNER

Under DSCSA, only authorized trading partners are allowed to do business in the pharma supply chain. Trading with unauthorized entities can severely compromise the integrity of the supply chain and may also lead to legal and financial repercussions for your business. Therefore, it’s best to get into the habit of verifying a trading partner’s identity before buying or selling to them.

When buying or selling to manufacturers or repackagers, ensure they are registered under the appropriate FD&C act. Similarly, while dealing with third-party logistics providers, dispensers, and wholesale distributors, ensure that they hold a valid state license.

REPORT LICENSURE

If you’re a third-party logistics provider or a wholesale distributor, you should ensure complete compliance with the licensure reporting requirements ahead of the DSCSA audit.

BE QUICK IN RESPONDING TO REQUESTS

To ensure seamless traceability and tracking, you must quickly respond to data reporting requests, primarily when the requests originate from the FDA or state officials. Moreover, DSCSA has put forward a two-day deadline for data reporting.

Therefore, having an electronic system can help automate this process, ensuring that all key information is shared promptly with the appropriate authorities.

CONDUCT REGULAR REVIEWS

Once everything above has been taken care of, start running regular system reviews to ensure everything is running as it is supposed to before the audit. Keep all your documents up to date and in line with the latest DSCSA developments. Doing this will help you ensure everything is in place for the audit.

FINAL THOUGHTS

From annual data reporting and verification requests to trading partner authorization, serialization and data retention, making sure that everything’s in place before the FDA audits begin might feel a bit overwhelming. However, with proper preparation, collaboration with other supply chain members, a reliable data reporting and tracking system, you can effortlessly pass the audit and become compliance-ready before the final deadline.