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Regardless of form, the regulatory function matters more

Regardless of form, the regulatory function matters more.jpg
Contractors looking to expand their capabilities must consider not only the challenges, but also that all the production requirements from a regulatory perspective are met. It’s a fundamental matter of form, fit and function.

The experiences of a career in all aspects of this industry continually reminds of universal truths. The matter of form, fit and function is one of those fundamentals.

When it comes to contract manufacturers, this is very much true for both sides of the contracted arrangement. There is more to the immediate identification of your contracted partner than just the simple ability to manufacture a specific product type. At the same time, contract manufacturers must continually evaluate their practices and consider the ramifications of expanding into other dosage forms or product categories.

Apart from the obvious matters of capability, there is first the evaluation of the quality of that capability. This comprises capacity, flexibility in terms of batch size, expertise and experience with the delivery form, and implementation of the proper equipment to move into the newer form. This includes not only the mechanical aspects of the requirements, but the regulatory needs associated.

Looking at it first from the perspective of the company seeking contract manufacturing of a ready-to-drink beverage, finding contract manufacturers offering services and seemingly demonstrating capabilities is not enough. As the contracting party your organization will be held responsible for knowing the performance of your contractor and its conformance to the requirements of the applicable regulations. This requires an initial, basic matchup.

The first determination is the product category. Is it a food? A dietary supplement? This will provide an initial screening of potential suppliers. Then the determinations involving delivery forms come into play. Having the capability to produce a product does not ensure the product won’t be considered adulterated by the regulatory agency. Matching the operations of the contract manufacturer solely to the product’s regulatory category, regardless of dosage form, is mandatory. Producing a liquid dietary supplement without employing dietary supplement GMPs results in the production of an adulterated product. Simple as that.

The considerations that must occur inside the contract manufacturer include the basic questions as to whether the operation is generally aligned with the regulations for producing a category of goods. The maintenance of two different sets of manufacturing, documentation and testing requirements is not a simple task. Maintaining an operation that handles both foods and dietary supplements involves the requirement for the establishment and implementation of a Food Safety Plan and attendant Hazard Analysis, Risk Based Control Point program, in accordance with the requirements of the regulations governing the manufacture of food as an additional burden that must be considered.

The maintenance of different standards for documentation must be addressed strictly and the additional testing costs associated with the production of dietary supplements tallies up rapidly. This consideration applies to all levels of contracting as well. Even an operation that only warehouses product must make determinations as to how to comply with the correct regulations for the products held.

As for the brand owner seeking the manufacturing, you are required to ensure that the processes used in the manufacturing of your product comply with the applicable regulations for that product category. When proceeding through the selection process, consideration must be given as to whether the primary operations of the candidate companies align with the regulatory requirements for the product type to be made. These first-cut evaluations will avoid a multitude of challenges going forward.

Even with the initial selection of a contractor to produce on your behalf and the appeal of alternative delivery forms ever present, there are limits. Understanding these restrictions is a fundamental first step—even before seeking manufacturers with the capability of producing the desired form of the product.

Specifically, foods and dietary supplements may only be ingested orally. Full stop. Drug delivery mechanisms include transdermal patches, but there is no category outside of drugs for transdermal delivery. Also, the presentation of any disallowed substance, in any form, results in adulterated produc;tthis should not require statement, but if it were that obvious we would not see the volume of such products in the marketplace nor the resulting regulatory actions.

The applicability of different dosage forms is appealing. When deciding what form to present, the initial regulatory concerns regarding restrictions and limitations must be addressed. Once that hurdle is crossed, a careful match-up of the mechanical capabilities of the contractor is insufficient if the operation is not compliant with the regulations governing the manufacture of the specific product category.

Contractors looking to expand their capabilities must consider not only the capability challenges, but ensure all of the requirements for production of a product from a regulatory perspective are met and those costs calculated before taking on the new endeavor. The form of the product is dictated by the fit of it in the manufacturing operation, with the function of the product a matter of employing the required processes out of the regulations for production. These performances are mandatory and understanding them is paramount to success from either side of the contract.

As chief operating officer, Jim Lassiter oversees all consulting operations at REJIMUS. He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries.

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