In-Process Quality Testing

GMP is basically a series of quality processes, such as holding, verifying, and then releasing. This is true for incoming raw materials and all in-process materials. This shows where some companies could make noncompliant decisions in the manufacturing process.

Let's look into the manufacturing and quality-checking process and use a capsule product as an example.

First, all of the ingredients, bulk capsules, and packaging need to be QC-checked and cleared. This is typically done by reviewing the raw material specification sheet, which shows what types of tests are needed. The samples are sent to a qualified lab and if everything passes, a member of Quality then releases the raw material.

Next is blending: All ingredients are weighed by one employee and verified by another (called the doer-checker system). They are then blended, and then a member of Quality verifies that the weight matches the projected yield and verifies organoleptics such as color and smell. If the projected yield is too low, then an ingredient may have been forgotten, and if it's too high, then there is likely some other issue like a duplicate or mis-weighed ingredient. If all looks good, then the blend is released to the next step in the process.

Next is encapsulation: A lot of variances can happen in the encapsulation process, so conducting R&D testing to ensure flowability and density is integral to a properly filled capsule. Quality typically checks the capsule weights consistently at the beginning of encapsulation, then about every 15-30 minutes to ensure they are weighing and looking good. After the encapsulation run is completed, Quality then verifies the projected yield of capsules to ensure they are within the predetermined range and releases them to the next step in the manufacturing process. If it is too high, then the capsules are underfilled, and the finished product will be below the label claim. If it is too low, then the capsules are overfilled, which may create a safety issue if there are ingredients that are unsafe at higher amounts.

Packaging: The projected yield is calculated from the number of capsules, and bottles are typically weighed consistently when the runs starts, then every 15-30 minutes to ensure the correct number of capsules is in each bottle. Then, the final calculation is reviewed to verify the number of bottles is within the projected range. If it is too high, then the bottle may be underfilled, which is non-compliant. However, if it is too low, that is not necessarily a compliance issue, but it can indicate a money-losing project. Quality then takes a few finished products for sample retention (a GMP requirement) and sends a bottle or two for finished product testing. Once the test results come back, they are written on the finished product specification sheet, and if everything passes, it is released for sale. Celebration time!

This lilypad approach to quality is designed to keep non-compliant materials out of the product facility and catch errors during the manufacturing process long before they reach the finished product.

Of course, I am simplifying this, as a lot more goes into making a compliant product, but I thought you might enjoy this "behind-the-scenes" look at what goes into making a compliant dietary supplement product.

DATE ORIGINALLY POSTED: 4/2/25

 
Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.