Vitamins are considered one of the most important minerals in keeping your mind and body healthy. Some vitamins combat against viruses and infections, while others encourage healing, make sure utmost body performance and promote vitality.
Because of their relevance, the dietary supplement industry is continuously on the rise, with many brands surfacing yearly, providing the most excellent quality dietary supplements. However, what is the manufacturing procedure behind this? Keep on reading as we will give you the step-by-step process of manufacturing vitamins.
This is where the whole thing starts. As an owner, you have made sure that your supplement formula utilizes the right doses of the best raw materials ingredients to offer a proof-based product, which will have efficacy and let you substantiate functions/ structure claims.
A well-produced dietary supplement needs the use of proof-based components to assists to ensuring the efficacy of the product. Ingredients might be chosen all over the world based on superiority and eying forms that offer high potency as well as bio-availability. For instance, a lot of mineral supplements take account of well-absorbed mineral salts mixed with organic acids, which include picolinates, citrates, and gluconates.
The first step starts when the owner of the brand submits a request for pricing to the CM or contract manufacturer. The manufacturer will make their own type of formulation and bear out raw material pricing for ingredients with different vendors. When done, the contract manufacturer offers a price quote to the owner.
Buy Order Submission
The true countdown starts when the owner of the brand submits the purchase order. After knowing the existence of a commitment, the contract manufacturer can start the process.
Ordering Raw Components
This is the most complex step in the process. In case you need probiotics as your raw material, as live microorganisms are normally made to order. They should be grown in a natural way, and that does not happen overnight. As a matter of fact, it may take six weeks or more to grow probiotics. If the raw materials come from overseas, meaning the finished material will be delivered internationally, that will take one to two weeks.
Certainly, there are lots of raw materials, not only probiotics. Some have improved stability and might even be stocked by the contract manufacturer or might not be stocked in enough amount; therefore, more will need to be ordered and usually will take two to four weeks to reach your destination.
Arrive of Raw Materials and Quarantined and Tested
If the raw materials get there at the contract manufacturer, cGMP rules need to be tested and quarantined prior to releasing to the inventory. The kind of testing needed takes account of potency and identity, heavy metal compliance, and microbiological compliance.
Potency and Identity: There must be an established approach for testing the material when it comes to potency and identity testing. Credible sources might give that approach. Aside from following the approach, the standard will have to be purchased when the CM does not already have the standard.
- Microbiological Testing
Materials should be tested for the compliance to microbiology to confirm that it doesn’t have dangerous levels of microorganisms like E. coli. A special tool in a part microbiological lab will be needed for this objective. The fact that all contract manufacturers don’t always have an in-house microbiological laboratory might signify that the material will need to be delivered to a 3rd party laboratory for micro testing. As a matter of fact, some contract manufacturers don’t even have a standard analytical laboratory, so testing will need to be done by a 3rd party laboratory.
- Heavy Metal Testing
This includes testing for mercury, lead, arsenic, and cadmium. Not just is this needed and the best thing to do, however, California Prop 65 needs is related to some high fines when the product doesn’t meet the stringent heavy metal needs.
- Bench Work
Contract Manufacturer will do bench work in which the materials will be combined. A limited quantity of capsules and tablets will be made in the laboratory to determine that the formulation will work in a completed dosage form. It depends on the situation; the contract manufacturer might give the client samples of the capsules or tablets to assess. If the customers approve the samples, the contract manufacturer can go on to the pilot batch.
- Pilot Batch
Utilizing what they found out during bench working, the contract manufacturer will run a pilot batch of the capsule on the real production tool. This is needed to know that the capsule will run suitably on the tool during the real production run. If issues occur, the formulation might require an adjustment that might need consent from the owner of the brand. If the whole thing goes very well, the contract manufacturer will go forward to the complete production run.
- Production Run and Testing
This is when the product will be produced. There are a lot of steps involve in this process, such as some extra testing. This takes account of the uniformity of mixture, content uniformity, testing dissolution, as well as a repeat of the examinations done on the materials.
- Uniformity of Mix: Raw materials that comprise a provided supplement are combined together in a big mix. It is essential the materials are totally and uniformly mixed to make sure that there’s an equal distribution of specified minerals, vitamins, herbs etc., in the whole batch.
- Content Uniformity: After figuring out the uniformity of the mixture, the next step that needs to follow is to make sure that every tablet has the right weight to confirm its nutrient potency.
- Dissolution Testing: This refers to the process of putting the tablet into a temp-controlled water and then move in a small container the same as the strapping action of digestion. Once the capsules dissolve in forty-five minutes of liquid, it’s reasonable to think that it will dissolve in your stomach, and its components will be absorbed.
- Stability testing: Once expiration dates s show on the product’s label, stability testing should be done. This assists in knowing which nutrients are prone to harm and to what level potency is affected.
- Accelerated Stability: In this process, the product in its planned packaging is put inside an environmental chamber that controls temp and humidity. The chamber will make conditions that are made to speed up the product’s normal aging.
- Ambient: This is determined by taking samples of the packaged capsules made and holding them in a room under controlled ambient humidity and temperature.
Testing of Finished Products
If the finished capsules have been made, repeat for the kinds of tests performed on the materials, including potency and identity, heavy metal compliance, and microbiological compliance. The contract manufacturer will make a COA that will be delivered to the owner of the brand. When the COA is approved, the product will be delivered to the storage, and the process is done.