What to Know Before Committing Natural Products INSIDER

June, 2011

Top 10 Questions toAsk Contract Manufacturers

Ask These Critical Questions Before Signing a Contract

• Brand owners that ask the correct questions up front will be able to better choose a qualified contract manufacture that can work with their specific needs.

• These critical questions regarding materials, suppliers, equipment, formulation techniques and written procedures will help answer the big question: Will this partnership hurt or help my business?

1.Can you produce the desired product?• It may seem obvious, but contract manufacturers differ in their abilities to

produce particular areas of the market, such as tablets, capsules, powders or liquids. Make sure the manufacturer has the auxiliary capabilities to handle the delivery form including lab testing, R&D services, label design/printing and packaging.

Adapted from “Turnkey Contract Manufacturing” by Bob Dunn

2. Can I visit your facility?

• Visiting the manufacturing facility can ensure everything is legitimate. Make sure the facility is in good working condition, well laid out, clean, conducive to producing the required products and built to meet cGMPs (current good manufacturing practices).

Adapted from “Turnkey Contract Manufacturing” by Bob Dunn and“Beyond cGMPs to Contaminant-Free Contract Manufacturing” by Joe Archer

2. Can I visit your facility?

• Visiting the manufacturing facility can ensure everything is legitimate. Make sure the facility is in good working condition, well laid out, clean, conducive to producing the required products and built to meet cGMPs.

Adapted from “Turnkey Contract Manufacturing” by Bob Dunn

3. Are you happy working here?• Talk to the staff to get a sense of their level of knowledge and expertise. Pay

attention to the manufacturing employees to see if they seem to enjoy their work. Manufacturers with an unhappy workforce tend to have more turnover and are more likely to encounter related production problems.

Adapted from “Beyond cGMPs to Contaminant-Free Contract Manufacturing” by Joe Archer

2. Can I visit your facility?

• Visiting the manufacturing facility can ensure everything is legitimate. Make sure the facility is in good working condition, well laid out, clean, conducive to producing the required products and built to meet cGMPs.

Adapted from “Turnkey Contract Manufacturing” by Bob Dunn

4.Can I see the specs for the raw materials included in my product?• The contract manufacturer should

provide a copy of a specification sheet with all of the testing that is expected to be performed plus the criteria for passing or failing the raw material, including identity, strength and potency, and continuation status.

Adapted from “Inquire About Incoming Ingredient Inspection” by Kevin Cloud

2. Can I visit your facility?

• Visiting the manufacturing facility can ensure everything is legitimate. Make sure the facility is in good working condition, well laid out, clean, conducive to producing the required products and built to meet cGMPs.

Adapted from “Turnkey Contract Manufacturing” by Bob Dunn

5.What instruments do you use to identify incoming raw materials?• The manufacturer should provide copies of the qualifications for each instrument

listed. A qualification is made up of three distinct parts: installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). Typical lab instruments include high-performance liquid chromatography (HPLC), gas chromatography (GC), ultraviolet visible spectroscopy (UV/Vis), fourier transform infrared spectroscopy (FTIR), high-performance thin layer chromatography (HPTLC), melting point (MP), microscope and near infrared spectroscopy (NearIR).

Adapted from “Inquire About Incoming Ingredient Inspection” by Kevin Cloud

2. Can I visit your facility?

• Visiting the manufacturing facility can ensure everything is legitimate. Make sure the facility is in good working condition, well laid out, clean, conducive to producing the required products and built to meet cGMPs.

Adapted from “Turnkey Contract Manufacturing” by Bob Dunn

6.What types of methodsdo you use to assay incomingraw material?

• A method, standard operating procedure (SOP) or set of directions, is essential to assay a sample, and it should be scientifically valid. Make sure the raw materials come from suppliers that can be qualified under the Part 111 regulation. Some recognized scientific compilations of methods are the U.S. Pharmacopeia (USP), American Oil Chemist Society (AOCS), Japanese Pharmacopeia (JP) and British Pharmacopeia (BP).

Adapted from “Inquire About Incoming Ingredient Inspection” by Kevin Cloud

2. Can I visit your facility?

• Visiting the manufacturing facility can ensure everything is legitimate. Make sure the facility is in good working condition, well laid out, clean, conducive to producing the required products and built to meet cGMPs.

Adapted from “Turnkey Contract Manufacturing” by Bob Dunn

7. Do you provide packaging and advice on finished goods labeling?

• Many outside label vendors are not familiar with the regulatory processes that affect the dietary supplement industry. A contract manufacturer with the expertise can not only design and print custom labels, but also watch for regulatory compliance. Labeling regulations are quite extensive, with primary label regulations for dietary supplements found at 21 CFR 101.36. However, additional labeling regulations for conventional foods also apply, principally found in 21 CFR 101 and elsewhere.

Adapted from “Getting to Worry-Free Manufacturing” by Richard Mihalik and“Essential Questions Related to cGMP-compliant Manufacturing” by Vince Paternoster

2. Can I visit your facility?

• Visiting the manufacturing facility can ensure everything is legitimate. Make sure the facility is in good working condition, well laid out, clean, conducive to producing the required products and built to meet cGMPs.

Adapted from “Turnkey Contract Manufacturing” by Bob Dunn

8.If the product takes off, do you have the capacity to meet the increased demand?• Asking about future planned expansions in production capacities can determined

whether the contract manufacturer can keep up with a successful product launch. Also, ask about planned equipment upgrades and improvements.

Adapted from “Getting to Worry-Free Manufacturing” by Richard Mihalik

2. Can I visit your facility?

• Visiting the manufacturing facility can ensure everything is legitimate. Make sure the facility is in good working condition, well laid out, clean, conducive to producing the required products and built to meet cGMPs.

Adapted from “Turnkey Contract Manufacturing” by Bob Dunn

9.Are all packaging components suitable to protect the product and for storage?• Packaging materials that comes in

contact with the product need to be free of filth and potential contaminants. Verify companies supplying packaging materials that are in direct contact with the finished dietary supplement are knowledgeable about the 21 CFR regulations that apply to those components.

Adapted from “Essential Questions Related to cGMP-compliant Manufacturing” by Vince Paternoster

2. Can I visit your facility?

• Visiting the manufacturing facility can ensure everything is legitimate. Make sure the facility is in good working condition, well laid out, clean, conducive to producing the required products and built to meet cGMPs.

Adapted from “Turnkey Contract Manufacturing” by Bob Dunn

10.Are you ready for anFDA cGMP inspection?

• An FDA inspection, the area of focus for Part 111 cGMP compliance, will include a thorough inspection of the facility, operations, components, quality control (QC), written procedures, documentation/record keeping, etc. The inspection also includes an intensive series of questions that detail each subpart of the cGMP rule. Of particular importance is whether all employees have completed cGMP training.

Adapted from “Essential Questions Related to cGMP-compliant Manufacturing” by Vince Paternoster

Asking questions about raw material sourcing, label issues, production capacity and cGMP compliance can help brand marketers ensure their contract manufacturers are fully in compliance with FDA regulations on dietary supplement manufacturing.

Asking first can prevent painful situations later ranging from lost time to FDA product seizure. In this case, what you don’t know can hurt you. But having the correct information can get you to worry-free contract manufacturing and product success.

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