Preparing for an audit

Supplement or natural product brand owners should be aware of FDA requirements under 21 CFR part 117. It’s the brand owner’s responsibility to comply with FDA on all matters dealing with vendor selection, approval and auditing. 

A supply chain program must include using approved suppliers, determining appropriate supplier verification activities, conducting supplier verification activities and documenting supplier verification activities. According to FDA, appropriate supplier verification must include onsite audits, sampling and testing of the product and review of the supplier’s relevant food safety records.

A contract manufacturer that doesn’t allow a visit to its facility or that doesn’t permit an audit (most excuses claim “secret stuff” is going on that doesn’t allow for anyone in the facility) should be a big red flag. Brand owners are required by law to visit, approve and audit their manufacturers. Therefore, if the contract manufacturer is a GMP-certified facility, it should welcome onsite visits.

The following are some simple steps in preparing for an audit. First, an outline of what is being audited should be created; this can be supplied ahead of time to the manufacturer in an effort to save time onsite. An audit should take one full day, at most, if done properly. A cliffnote book on FDA’s 21 CFR part 111 can offer guidance as to what the manufacturer’s responsibility is. These are the same books FDA auditors carry while doing onsite audits.

The audit checklist should include a tour from start to finish, with the manufacturer explaining its flow process. Questions can help a brand owner to understand how a product from receiving to shipping flows. During this tour, the brand owner needs to pay close attention to cleanliness, organization, proper lighting and covers, whether employees are wearing the proper gear, and what procedure is in place when entering the facility. A note pad is useful to document findings. Most manufacturers will not allow cameras inside the production area due to confidentiality agreements with other brands that may be running during the time of the audit.

The tour should also include a thorough look at a contract manufacturer’s quality control (QC) laboratory. Brand owners should ask questions about the manufacturer’s testing program and what is done to ensure products will be made according to specifications. After the tour, standard operating procedures (SOPs) should be reviewed. A table of content can provide an overview of what SOPs a manufacturer has in place. Comparing the written SOPs to what was uncovered on the tour provides insight as to whether the manufacturer is doing things according to its SOPs. Speaking with the quality assurance manager, QC manager and production manager is critical to ensure they know government procedures.

If the manufacturer’s facility is clean and organized, and they have answered all questions openly, honestly and according to the code of federal regulations, they can receive a passing grade. It’s critical to document the tour, design a vendor approval form to fill out and include all notes with this approval. These records should be saved and filed in a safe place so they’re accessible in the event of an FDA audit.

Jeff Golini, Ph.D., is a multi-patent holder, inventor, author and scientist currently working at the helm of All American Pharmaceutical as CEO and excusive scientist. Golini has also published several studies and is the host of National Radio Shows “Science for Humans” and “The EFX Sports Show” heard live on ESPN 910 Radio. Golini founded St. Anthony’s Research & Education Institute.

Looking to know more about the regulatory responsibilities of a contract manufacturing partnership? Join us for the "Managing Quality in a Contract Manufacturing Partnership" workshop on Saturday, Nov. 10, at SupplySide West 2018. This workshop is underwritten by Sora Laboratories.