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Dosage Format Transparency with Your Contract Manufacturer

Your contract manager is the success factor of your product. To get the desired product, you need a contract manager that can understand all your needs and fulfill those requirements in a quality manner. You cannot simply trust on mouth words. There must have some criteria to find out the ability of the manufacturer. You can’t even rely on past deliveries as each new product requires new consideration and different levels of handling. [1]

The main factor that is considered during the manufacturing of a product is controlling the safety of the product. When dealing with manufacturing, some formulas require high safety standards. A product should not be harmful in use in any way. The second factor is the stability and shelf life of a product. What you will do of a product that is not stable and has a lesser shelf life. Liquid products are more prone to stability issues.

The selection of dosage form is the main issue faced. Sometimes it is based on the consumer’s choice and sometimes it depends on the supplement ingredients which form to choose. If seen from the consumer’s point of view, tablets and solid forms are much more in demand. However, a high increase in the demand for other forms of supplements is also seen, such as gummy supplements and oils. 

The choice of selection is based on a number of criteria, such as suitability of ingredients, availability of ingredients, costs involved, customer preference and market demand. There are no basic criteria for herbal and dietary supplements but there are some criteria that are to be followed. Under the Dietary Supplements Regulations 1985, dietary supplements are regulated which fall under the Food Act 2014. If the product is containing some animal food, the Animal Products Act of 1999 or the Food Act of 2014 also needs to be followed. Federal regulations of each country demand that the manufacturing and selling companies are responsible for the safety of the product. They are also responsible for declaring all the ingredients on the product label and do not mislead the customers. The companies are on the verge of legal action if their supplements are found unsafe for human health.

Dosage Forms Handling Requirements

The main factor in the stability of a product is water. Most products are differentiated on the base of their water content, such as capsule products and powder products require different levels of water content. Water is the main component that aids the growth of micro-organisms. Failure to control the growth of micro-organisms inside a product and not emphasizing on safety procedures may lead to the failure of the whole product. Such products whose water levels are not controlled during the shelf period may become fatal over the course of time. [2]

Extensive consideration is to be given for the products which contain high moisture components. It is not necessary that if a manufacturer is dealing best in dry products such as powder and tablets, will always work in the same way for liquid products. It is necessary to ensure the manufacturers’ ability to handle variations in product manufacturing.

Liquid & Dry Products

Both liquid and dry products are made from the combination of different foods and supplements such as vitamin-rich mushrooms, food sources, and different plant-derived substances. Industry based standards for risk evaluation of food are necessary to be done. But they do not require the individual testing of each component which is going in the product.

Coming to dry forms of products i.e. capsules and tablets, each of them requires a different set of procedures. The manufacturing requirements may vary based on how those products are labeled. If a dry product is labeled as a food supplement, supplement GMPs must be followed. The supplement GMP procedure requires that all product ingredients should be verifiable with testing, and the amount of each ingredient should be mentioned and its results are tested.

A manufacturer will either have the capacity of following a single GMP. Some will follow a food GMP and some will follow a supplement GMP. However, there are manufacturers who have the ability to follow both systems. Such manufacturers produce high-quality products.

It is important to categorize and label your product either as a supplement product or food product. A dietary product is required to have the same amount of ingredients that are mentioned on the product label. On the other hand, it is more important for a food product to maintain its taste and color throughout the entire period of the product until its expiry date comes.

Mixing Of Ingredients

Another important aspect of product completion is the proper mixing of ingredients. It is easy to assume that the components will mix instantly, but it is difficult to process. There is a hectic procedure for ingredient mixing and sometimes the fault that the ingredients are not mixed properly is realized even at the time of product completion. This leads to the destruction of the whole batch of production.

Shelf stability is a lifesaving feature of the product that cannot be ignored. Accruing shelf stability for a product has many challenges. Even a little mistake may lead to product failure. A manufacturer must fully understand the product requirements to acquire shelf stability. Proper documentation of each step is also necessary. There may come a variation each time a product is made. There are multiple reasons for variation. The way to control variation is by doing proper stability study and having complete control over ingredients maintenance and processing requirements.

Personal Requirements of Workers

All people working in the manufacturing area are required to have proper training, relevant information, and required experience to produce a quality product. The company is required to provide necessary courses to employees that are relevant to the working domains of each individual.

Proper documentation of training values is necessary to compete with safety standards.

The supervisor should manage his team in a manner that there is a guarantee of final results that the final product has the right characteristics, quality, safety, and cleanliness standards that are necessary to show.

Disease Control

If a worker is diagnosed through medical inspection or supervisory opinion that he possesses an illness such as infected wounds, boils, sores, open cuts, or is prone to direct source of microbial contamination which can result as an in-process or final supplement product becoming contaminated, packaging materials or utensils, and processing equipment becoming dirty, shall be stopped immediately from work. He should not be allowed to work in such situation which may be expected to outcome in contamination of supplement until the person becomes fully healthy. Supervisors should take note of a worker’s health and should take reports on a daily basis.

Cleanliness

Employees who are working directly with raw materials, the procedure of making or finished supplement products, equipment, machinery, or packaging process should be advised to follow proper hygiene and cleanliness rules during the working hours. This will prevent contamination of ingredients and final products.

Special Handling Requirements

All supplement manufacturers are required to deliver pure and ultra-safe products of daily use. The manufacturer should have the proper ingredient handling equipment. Complete warehousing of all products is also compulsory. Firm sugar and ingredient coating equipment is required during the manufacturing procedure. Manufacturers also need quick processing time that will control the cost of overall manufacturing.

A manufacturer must also identify the product requirement after the packaging procedure. If a product needs special protection after packaging, it should be clearly written on the product bottle. “Keep Frozen”,” keep refrigerated, “Keep frozen or refrigerated”, “Protect from heat”, “Protect from sunlight”, “protect from heat and sunlight” are some examples. Also, safe handling instructions should also be mentioned on a handy draft provided along with the product. The product should be officially inspected before delivering it in the market.

Why You Should Choose SMP Nutra as Your Manufacturer?

SMP Nutra provides you with a wide range of manufacturing options to choose from. We are capable of manufacturing any type of nutraceutical formula and also can provide flavoring services along with offering a wide range of packaging options for your product. With our team having more than 50 years of experience in the nutraceutical industry, we can guarantee some of the highest quality end products and best customer service. If you have any questions or need any help, you can contact us here.

References

  1. https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/new-england/regulatory-challenges-and-trends-in-finished-dosage-manufacturing—a-cmo-perspective.pdf?sfvrsn=4
  2. https://www.vitafoodsinsights.com/contract-manufacturing/questions-you-need-ask-find-contract-manufacturer

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Will Cartwright

Will is a Co-Founder of SMP Nutra, founder of GetKnownPros, and owns a handful of supplement brands. Will has extensive knowledge of trends in the nutraceutical industry after contract-manufacturing for hundreds of brands. Will has spent the last decade learning the best online marketing & brand-building techniques for supplement & vitamin brands and enjoys sharing this unique knowledge with his nutra-entrepreneur community.

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