Dietary supplement rework control operation process

The core logic of legal and compliant dietary supplement rework control is "traceability and determination → hierarchical disposal → full-link verification → closed-loop traceability". All operations must comply with the requirements of the "Health Food Good Manufacturing Practice" (GMP), and changes in product formulas, consumption methods and shelf life are strictly prohibited. Any rework that exceeds the bottom line of food safety is an illegal operation.

I guess people in the industry would laugh when they see this. Isn’t this a cliché? But when it comes to implementation, the practices of each factory are so far apart that the industry is now divided into two factions that are quarreling with each other: one is the "zero return labor force". As long as the batches are returned after leaving the factory or are found to be unqualified in the production process, all batches will be destroyed regardless of the size of the problem, and there will be no room for rework. ； The other group is the "Controllable Rework Workers", who believe that as long as the problem lies in the non-core links of the content, or if the rework can pass all verifications, it can be legally reworked, and there is no need to waste costs. I have visited more than 40 dietary supplement production factories across the country and have seen both models. I can’t say who is right or wrong. The core is just the red line of food safety.

If you really want to start rework, the first thing you should do is not rush to unpack and rectify. You must first dig out the root of the problem clearly, without any ambiguity. Last year, we encountered an incident at a vitamin C effervescent tablet factory in Guangdong. During a random inspection, it was found that the disintegration time of half a batch of effervescent tablets exceeded 2 minutes. At first, the workshop director thought that the tableting pressure was too high, and planned to take the tablets back and re-press them. As a result, we followed the production records and raw material test reports for three days, and finally discovered that the crystallinity of the batch of citric acid did not meet the standard. If the tablets were pressed directly at that time, the subsequent tablets would still have problems. When tracing the source, you must go through all the batches, raw materials, equipment, and operators involved to determine whether the problem is isolated or systemic. If it is systemic, such as inaccurate ingredient scales, you must first calibrate the equipment and recover all the previous batches involved, and then talk about rework. Otherwise, your work will be in vain.

The next hierarchical treatment is where the industry differs the most. If the outer box is printed incorrectly or the label is crooked, which does not involve the content, the entire industry basically agrees that it can be reworked. As long as the old packaging is dismantled outside the clean area, re-labeled and packed, and each box is scanned to ensure that the information is correct, there is no controversy. But if it comes to the issue of content, there are many opinions: For example, if the tablet weight difference after compression exceeds the standard, some factories think that as long as the tablets are disassembled, re-screened, mixed and pressed again, and the site is cleared and cross-contamination prevention and control is done, there will be no problem. ； However, some factories feel that the pressed tablets have already reached a certain degree of molding, and the uniformity of remixing cannot be guaranteed, so they would rather scrap them than touch them. There are also those soft capsules that leak. Some factories will pick out the intact ones and repackage them, and some will directly send the entire batch for incineration. There is actually no unified mandatory standard for this. The core is whether you can produce enough verification data to prove that the reworked product meets the quality requirements - after all, during the unannounced inspection, they only look at the evidence and do not listen to your explanation.

No matter which processing method you use, the verification process after rework is absolutely unavoidable, and is even much stricter than the testing of normal production. Normally produced batches only need to undergo all factory inspections, while reworked batches must undergo at least three additional tests: First, cross-contamination testing. For example, if you are reworking lutein tablets and the workshop has just produced iron supplements before, then the iron content must be tested to ensure that it is not mixed in. ； The second is an accelerated stability test. The reworked product is placed in an environment of 37°C and 75% humidity for 3 months to see if the content and disintegration indicators will fall faster than the normal batch. ； Third, the sampling ratio should be doubled. For normal samples, 20 pieces will be taken, and for reworked samples, at least 100 pieces will be taken. Samples from each rework process must be retained. I once encountered a factory that reworked a batch of protein powder. I thought it was just repackaging without touching the contents, so it was lazy and did not do microbial testing. As a result, the final factory inspection showed E. coli. It was found that the employee's gloves were torn during repacking and were not changed. If there was no card verification process at that time, it would be a big deal if it leaked to the market.

All rework processes will eventually be reduced to paper, and nothing can be saved. On what day the rework was started, what was the reason for the rework, how much quantity was involved, how much wasted, who was the operator at each step, what was the test report, and how many were finally qualified, all these records must be nailed to the back of the batch production record of the original batch and kept for at least 5 years. When the regulatory authorities come to investigate, the entire ins and outs can be clearly understood in one glance. Don't think that the records are for supervision. If there is a consumer complaint, you can only tell the problem clearly by getting the complete rework verification record. Otherwise, the yellow mud will fall off your crotch, which is either shit or shit. There is another small detail that is easily overlooked: the batch number after rework must be marked separately. For example, the original batch number is 20240501, and the reworked batch number is added with a suffix "R" to become 20240501-R. No matter which channel it flows to later, as long as you see this suffix, you will know that it is a reworked product, and if there is a problem, it can be quickly recalled.

I have been in this business for almost 10 years. I have seen people who violated regulations and reworked in order to save hundreds of thousands of dollars and were fined millions in the end. I have also seen people who burned hundreds of thousands of goods because they had mislabeled them. To be honest, there is no standard answer to the matter of rework. The only bottom line is: Do you dare to feed the products you rework to your family? If you dare, do it. If you don't dare, destroy it as soon as possible. Don't take chances. After all, dietary supplements are what you eat. If something goes wrong, the entire brand or even the entire industry will be affected.