Inside a GMP Inspection

by Amy Caplette

As the deadline approaches for all companies manufacturing dietary supplements to be compliant under federal GMPs (good manufacturing practices), FDA inspections will become increasingly common. Wondering what to expect when FDA shows up at your door? So was our team at Amway Global, which was one of the first companies in Southern California to be inspected by FDAa new experience for both parties.

The FDA investigator identified raw materials and products to follow through our supply chain (e.g. botanical, vitamin, mineral). At the end of eight days of inspection, a walkthrough diagram would have looked liked an intricate pattern created by a spider. Because the majority of Amways supplements are manufactured for global markets, it was difficult to set up a linear walkthrough from receipt of materials to the shipment of finished products for the United States. Based on this experience, companies should work with their supply chain planning and manufacturing groups to optimize the inspection walkthrough. Furthermore, be prepared to hold production in order for the investigator to observe the process.

Each day of the inspection was a mixture of observational walkthroughs, interviews and document review. At the time of the inspection, the investigator did not have a guidance document to facilitate FDA expectations. However, the investigator did utilize the Code of Federal Regulations (CFRs) to ask questions by following every subpart in 21 CFP part 111; this process was tedious and necessary for the investigator to establish and confirm GMPs.

In addition to educating Amway on the process, the inspection also became a classroom for the investigator, who began to interpret the regulation against facility processes, while we asked clarifying questions about the supplement GMPs.

Overall, the inspection is geared to identify whether a company has the necessary systems in place, and identify if the system is in control to assure compliance. The following items are necessary to have for the inspection:

With the proper preparation and awareness of the audit process, companies will better handle a GMP inspection and should learn a few things to improve both their operations and their readiness for future audits.

Amy Caplette is group leader in Nutrilite/Amways QA department and is a certified quality auditor. She has extensive experience with GMP compliance, and has developed quality programs such as customized GMP training, gold medal audits, environmental monitoring and integrated pest management.