Dietary supplement rework control operation process

All rework operations must be in compliance with the "Health Food Registration and Filing Management Measures" and "General Hygienic Standards for Food Production" as the absolute bottom line. The quality of the final product must not be lower than the standard of qualified products of the same batch. The entire process is traceable and there is no risk of cross-contamination. This is a non-negotiable hard requirement.

Don’t think this is empty talk. When I worked as QA in a head health care products factory in the Yangtze River Delta two years ago, I saw a real negative example: that batch of 30,000 bottles of Coenzyme Q10 soft capsules only had 10mg more active ingredients on the bottle label. The boss wanted to save trouble and let the workshop A new label was directly attached to the original label without going through any rework approval process. As a result, it was inspected by the city supervisor and fined more than RMB 800,000 for label non-compliance. It also caused the registration numbers of three cooperative brands to be warned, and they were unable to update the goods for half a year. The losses were far greater than the cost of directly destroying the goods.

Speaking of this, I have to mention two operating ideas that have been arguing in the industry for five or six years. There is no absolute right or wrong, but the scale and risk tolerance of each factory are different, and the paths they choose are also different: one is the "cost priority school", as long as it does not involve the safety of the contents, rework can be done. After all, the cost of raw materials, packaging materials, and labor has increased sharply in the past two years. If tens of thousands of bottles are destroyed, a small factory with an annual revenue of tens of millions will really not be able to bear it.； The other group is the "risk-first group". Unless there are defects in the external circulation process that do not come into contact with the contents (such as printing errors on the outer box, damaged express boxes), rework will not be done in other cases. This is especially true for raw materials with high activity, such as probiotics, sodium hyaluronate, and SOD, which are sensitive to temperature, humidity, and environmental exposure time. During the rework process, even if they are exposed to room temperature for more than half an hour, the activity loss may exceed the standard requirements, and the problem will become bigger as time goes by.

No matter which school of thought you prefer, there are several hurdles that cannot be jumped over. They are all practical experience gained by paying hundreds of millions in fines in the entire industry, so don’t be too troublesome.

The first thing that cannot be avoided is the risk assessment and approval before rework. There are three levels to go through: first check the nature of the unqualified item. If the content of microorganisms, heavy metals exceeds the standard, and the content of functional ingredients deviates by more than 20%, don’t say anything and go directly to the destruction process. There is no value in rework.； The technical feasibility of re-stuck, for example, can the icing of gummy candies be re-starched? You must first do more than 3 small tests in the laboratory to see if the new icing will brown with the original icing, and whether it will cause degradation of the functional ingredients. Only after passing the full test can you submit an application. ； Finally, you have to go through a double-signature check, where both the quality manager and the production manager sign for confirmation, and the rework plan must be reported simultaneously to the food and drug-related departments of the local municipal supervisor for filing. Don’t mess around in the workshop secretly. If caught, you will be punished.

When it comes to the actual rework operation, the operations of different non-conforming items are very different. You will understand by citing the two most common scenarios. If it is just a problem at the packaging material level, such as the wrong shelf life in the printing code, the label is crooked, or the outer box has creases, it must be operated in a separate isolation workshop and cleared in advance. All materials and packaging materials unrelated to this batch must be cleared out. The old packaging materials that have been replaced must be counted on the spot and shredded with an industrial shredder. There must be QA standing by to keep an eye on the whole process, and the old packaging materials must not be allowed to leak out - I once had a colleague who wanted to save trouble and sold the 10,000 wrong version of the fish oil labels as scrap paper. As a result, the criminals took it and filled it with fake squalene. Finally, the source was traced to their factory, and they were fined 300,000 yuan. It was a huge injustice.

If it involves reprocessing of the contents, such as the friability of the compressed plain tablets is not up to standard and the filling amount of the hard capsules is too large, the controversy here becomes even greater: many factories think that they only need to crush the plain tablets, pour out the contents of the capsules and re-granulate them, and as long as the final inspection passes, there will be no problem. , but there are also many people on the research and development side who object. For heat-sensitive ingredients such as B vitamins and vitamin C, if they are repeatedly granulated and heated, the content loss may exceed 15%. If tablets are directly pressed without content verification, the functional ingredients of the final product may not meet the standards. The rules of the factory where I worked before were that when it comes to the rework of the contents, in addition to regular small tests, at least three batches of pilot tests must be conducted for verification. The additional raw materials must also go through the same factory inspection process as new raw materials. Only if there are no problems can we continue.

Don't think everything is fine after the rework is completed. Inspection is where it's easiest to cut corners and create big pitfalls. Many people have misunderstandings: I reworked the work just because the friability was not up to standard. Wouldn’t it be over if I checked the friability? Absolutely not. I stepped into this trap in 2019: The reason for returning a batch of melatonin tablets was that the friability exceeded 0.3%. When re-granulating and pressing the tablets, the new operator forgot to add magnesium stearate. As a result, the friability of the tablets was acceptable, but the disintegration time exceeded by more than 20 minutes. If only the friability had been checked at that time, the tablets would have been released, and they would have been unqualified products on the market. Therefore, the rules in the industry are that reworked batches must be fully inspected, and the requirements are exactly the same as newly produced batches. Risk items that may be introduced during the rework process must even be tested: for example, re-crushed contents must be tested for microorganisms, re-sprayed codes must be tested for coding adhesion, and re-sugar-coated products must be tested for accelerated shelf life testing. Don’t be too troublesome, missing any one of them may lead to big problems.

Finally, there is a point that many people tend to overlook: all rework-related information must be kept. Reasons for rework, pilot and pilot reports, approval signature records, operators/times/amounts of materials used in the rework process, old packaging material destruction records, and full inspection reports must be kept for at least 5 years and placed together with the batch records of normal production. They must be available at any time during the city supervisor's unannounced inspection. If anything is missing, it is considered non-compliance.

In fact, everyone in our food production industry knows that rework itself is a "last resort" matter. It is the most economical and safest way to control every step in the production process and avoid rework as much as possible. If you really need to rework, don't take chances and skip steps. Don't skip any step in the process. After all, dietary supplements are eaten into the stomachs of consumers. You can't be too careful, right?