06 Feb 2017

10 Valuable Questions For Choosing A Contract Manufacturer

By Kathy Paffendorf

_dsc4822-lThe role of the contract manufacturer (CM) involves more than manufacturing and supplying ingredients.

The CM plays a critical role producing a compliant quality product for your label that stands up to all regulatory scrutiny and consumer safety parameters. As such, they should function as a reliable extension of your organization.

The real value the CM brings is building a dependable lasting partnership with you and bringing you peace of mind.

Here are valuable questions helping you choose the right Contract Manufacturing Partner.

1. All-In-One Custom Manufacturing Resource: “What types of turnkey processes do you have?”
In a total turnkey process, you and your CM outline, define and agree on respective responsibilities and deliverables.

Common discussion topics include sourcing of raw materials, meeting specifications, testing standards, QA & QC, R&D, SOP, and meeting label claims, among other areas pertaining to the specific needs of your organization.

Also inquire what are the CM’s first-order lead times. Are their lead times current, and is there a cost to do a trial or scale ups.

An experienced staff with an extensive knowledge base can walk you through the varying nuances in processing.

2. Certifications: “What types of certifications do you have…cGMP, NSF, NOP Certified Organic, FDA GRAS, Non-GMO, HAACP, Halal, Kosher… and do they fall within my end product?”
This includes the CM supplying full dossier of statements that your organization needs for your regulatory file. And, the CM verifying the existence of any allergens, investigating non-GMO or other status required for your ingredients.

3. Insurance: “What levels and types of insurance do you carry…are you fully insured for general liability, umbrella, product liability, and claims-made coverage?”
Just as the CM performing to your expectations is important, so is having proper insurance minimizing potential liability in the event something happens to your product.

4. Local Health Certifications: “Do you have all of the appropriate plant facility registrations required by state, health, and other applicable governing agencies…and what are they?”
Registrations, rules, and regulations pertaining to operating plant facilities vary by state, and by location.

5. FDA Registration: “Are you registered with the FDA?”

In addition to asking this question, arrange an on-site tour of the plant facilities. The condition of the site, documentation preparation and review, material safety data sheets (MSDS) being onsite in the laboratory, and other manufacturing requirements will be transparent to you.

6. Laboratory: “What kinds of testing can your in-house lab do…micro, stability, active ingredients, gluten, melamine, Prop 65…and do you send any testing to a third-party accredited lab?”
The CM assures proper certifications and registrations for its in-house laboratory and / or certified third party. Ideally, they will also have a sample retention program in place to help achieve compliance.

Additionally, nationwide distribution for the end product means the CM’s lab testing for ingredients must meet Prop 65 scrutiny.

Working with an experienced CM staff familiar with the potential “chemistry response” of some ingredients that don’t pair well can avert negative impact on the finished product.

7. Regulatory Documentation: “Do all of your ingredients have all the regulatory documentation I need for my label?”
An experienced CM staff will guide you through all regulatory documents required for the end product including SIDI documentation.

8. Environmental Safety: “What is your recent safety and environmental history?”
Topics may include environmental impact, cross contamination, resource efficiency, recycling, or other applicable concerns.

9. Warehousing: “What kinds of warehousing facilities do you have available and where are they located?”
Warehouses convenient to your locale or distribution centers factor into your timeline and costs. Refrigeration and frozen capabilities may also be required for the stability of certain products, such as probiotics.

10. Alternate Location: “Do you have an alternate location with the same production capabilities in the case of emergency planning?”

Asking the right questions will bring you one step closer to finding the right contract manufacturer that works for you. Pharmachem Laboratories, LLC has served as contract manufacturer for a variety of customers since 1979. To learn about Pharmachem’s certifications, processing services, and more, visit pharmachemlabs.com, or call 800-526-0609 (201-246-1000 outside the U.S.).

kathy-paffendorf-image1Kathy Paffendorf, sales account executive, Pharmachem Laboratories Inc., has been in the dietary supplement industry since 1980. She was previously with Chr. Hansen and Pure World Botanicals (acquired by Naturex in 2003).