Who's making your product?

Increasingly, dietary supplements are distributed by marketing companies that don't manufacture the products themselves. Compliance expert Brian Frisby offers a primer on selecting the right contract manufacturer

In today's growing dietary-supplements market, smart distributors and marketers continually evaluate the capabilities of their contract manufacturers due to impending stricter regulations, regular testing by consumer 'watchdog' groups, and new requirements from mass-market and health food chains.

Here are some important issues you will want to address as you evaluate a contract manufacturer's capabilities to meet today's market requirements.

What do they make?
First, check out the products the prospective contract manufacturers currently make. Do they have a speciality? Some are good at formulating and manufacturing tablets while others are good at making capsules or powder-filled products. Liquids are a speciality all their own and require specialized equipment and training in order to make a product that remains stable on a store shelf. Ask the manufacturer for samples of the finished products so that you can evaluate the quality. Is this something you would buy?

Don't forget about your customers' volume demands. Is this manufacturer able to produce the amounts your customers may require, or will you experience late shipments and out-of-stock situations?

Check with others
What companies are currently manufacturing similar products in the market you're in? What kind of reputation do these companies have? Do the products in the store appear to be well made and well packaged?

Visit the facility
Arrange to visit the manufacturing facility for a tour and preferably an in-depth 'audit.' This is your first clue about a potential contract manufacturer. How do its representatives react to the request for a visit? Are they open and willing to receive you? Are they willing to quickly make an appointment? Do they ask you what you wish to see?

Any hesitation on their part is a 'red flag,' and should cause you to look for another manufacturer for your product.

When visiting a facility, check for some of the following issues and capabilities.

GMP compliance
This is the big one, and cannot be emphasized enough! Good manufacturing practices (GMPs) are rules mandated by the US government to ensure the safety, purity and, in some instances, the efficacy of dietary supplements as well as foods, drugs and cosmetics. GMP compliance covers all areas of warehousing, storage, processing, testing, cleanliness, record keeping and traceability. When touring a manufacturing facility, it is helpful to be familiar with GMPs, or have someone with you who is.

Lack of compliance to GMPs in the manufacturing facility is one of the most common reasons for FDA product recalls.

Check to ensure that the facility has a complete set of current standard operating procedures (SOPs). These procedures should clearly describe how all products are ordered, tested, stored, processed, packaged, labelled and shipped by the company. SOPs should be written not only for the complete facility, but also for each specific area within the plant. SOPs cannot be too specific and they should clearly describe how all products are processed throughout the plant.

Is the facility clean? Is it orderly and neat? Does it appear to be well maintained? Do the floors appear to be washed, and are they free of trash and extraneous materials? Are window ledges, desks, shelves and equipment free of dirt and dust? Are walls, floors and ceilings well maintained and in good repair? Are processing rooms clean and in good repair? There should be no leftover product build-up in the corners or on flat surfaces. All material containers should be clean and sanitized.

Are there vacuum systems to keep dust out of the air and avoid cross-contamination of products while being processed? Are the vacuums cleaned and maintained on a regular basis?

The bottom line: would you feel comfortable taking products manufactured in this facility?
Personnel should be required to wear gloves and hairnets (face covers if facial hair is present) when working around open products or inside of processing rooms. In addition, many companies provide uniforms or at least lab coats for their operators in order to promote and maintain cleanliness in the facility. The bottom line here is: would you feel comfortable ingesting products manufactured in this facility?

Does the equipment appear to be well maintained? Each piece of equipment should carry a 'status' label — for instance, 'clean and ready for use,' 'do not use, needs cleaning,' 'shut down, needs repair' or 'needs calibrating.'

Equipment should be clean and free from dust and/or leftover product from a previous run, as well as clean of excess grease and chipped paint (older equipment). It should not have materials such as tape of any kind or bare wires that are being used to augment the processing of the machine.

The facility should be designed and constructed for easy cleaning and maintenance. The flow of goods from storage through processing and packaging should be clear and straightforward. This limits the risk of processing products in the wrong way due to misallocation within the processing area.

There should be physical separation between processing equipment as well as between packaging lines and stations. This ultimately diminishes the risk of 'misbranding' due to the wrong product being processed on the wrong machine or packaged on the wrong packaging line.

All products stored in the warehouse area of the facility should be clearly labelled with product names, lot numbers and product quality assurance status (in other words, 'released,' 'holding for test,' etc.). There should never be 'quarantined' or 'rejected' material in the general warehouse or in the processing or packaging area.

Quality control and assurance
Companies are required to maintain a quality-control or quality-assurance department. Individuals in this department are responsible for monitoring all processes throughout the facility. This department is responsible for ensuring that records are properly kept and that processes and personnel are functioning within compliance of the company's SOPs and ultimately compliant with GMPs.

Ensure that the company uses a certified-supplier program that requires its vendors to be GMP compliant — that will save you headaches in the long run.

Does the manufacturer have an 'in-house' laboratory? Are products forwarded to an outside lab on a regular basis? What type of testing is routinely performed? Essential tests include microbiological tests on raw materials and/or finished goods, identity tests for botanicals, and assays for vitamins and minerals. In addition, good manufacturers carry out some type of product-stability programme to guarantee the product potency and freshness for the shelf life of the finished product.

Confirm that the company keeps meticulous records of all its products. It is required to track all raw materials lot by lot through its facility, as well as all finished goods shipped from the facility. Properly maintained records clearly identify each lot of raw material, where it came from, how much of it was received, when it was received, the testing performed on it and what specific lots of finished products each raw material was used in.

Thinking ahead
New GMPs specifically written for the dietary-supplements industry are due to be published at any time. Government red tape, political concerns and continual changes at the FDA have delayed the long- awaited 'final regulations.' However, experts believe that the new regulations will require a higher level of compliance compared to the existing patchwork. From your perspective, it is important that the companies you are talking with are familiar with the regulations under discussion and are making attempts to comply with them now.

Brian Frisby is a veteran of operations and manufacturing management in the dietary supplements industry. He was executive vice president of operations of Marlyn Nutraceuticals/Naturally Vitamins, and director of quality and regulatory compliance for Nature's Way. As business development manager for Capsugel, he offers customers strategic counsel in business growth. www.capsugel.com

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