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Quality and Third-Party Certifications

<p>Certifications for GMP compliance of contract manufacturers and contract labs are popular in the supplement industry, but they do not guarantee complete fulfillment of regulations.</p>

Even for startup firms in the dietary supplement industry, obtaining a third-party verification of cGMP (current good manufacturing practice) compliance is considered an important goal, especially for contract manufacturing and contract laboratory testing activities. The reasons range from being able to put a “cGMP Certified" logo on a product label (or the lobby wall), through to a commitment to ensuring fully compliant quality systems. Certification may also help to lower the risk of FDA finding serious cGMP violations during inspections. Companies that are certified or accredited may also be able to avoid the overhead of hosting multiple audits from clients, although in practice, many firms prefer not to rely solely on a certification and request in-person visits regardless of the certification.

An example of an accreditation that is commonly used both inside and outside the dietary supplement industry is ISO 17025:2005, which is typically sought by analytical testing laboratories to help improve their quality systems and technical operations, as well as providing assurance of testing expertise to their customers. The accreditation process ensures that the relevant laboratory and organizational operations meet the ISO requirements. ISO 17025:2005 accreditations have a “scope" associated with them, which indicates the specific testing areas in which a laboratory has expertise and to which the accreditation applies. The scope may be limited to a narrow range of analytical methods and must be published along with the accreditation certificate. Clients can then check whether the ISO applies to the test they need performing.

Several organizations currently provide cGMP certifications or registrations for the supplement industry, including NSF International, USP, the Natural Products Association (NPA) and UL. These programs vary in cost and emphasis, but share a common pattern of performing periodic audits to a standard set of requirements. The general scope of the certification—e.g. the applicable cGMPs—may make it harder to evaluate what exactly has been certified, and that is something that a prospective client must investigate. For example, a UL Certificate of Conformance will list the scope of operations that were examined, and a prospect must ensure those are relevant to the contract being considered. If the scope is for packaging and labeling dietary supplements, but a firm is looking to formulate over the counter (OTC) drugs, the certification may not be relevant.

A certification provides evidence the firm has reasonably compliant quality systems in place and is able to handle audits and inspections proficiently. However, a certification audit is not a guarantee of having no findings of regulatory noncompliance in a subsequent FDA inspection. In an audit or inspection, the opinions and particular training of an individual may result in different outcomes. A firm that is considering using a contract manufacturer may still prefer to audit in-person rather than simply trust in the certification, and indeed this is the best advice (trust but verify). That applies doubly to situations where a firm is certified by an organization that has no official recognition or affiliations, which includes certifications issued by small consulting firms or individuals. In the end, potential customers must evaluate the quality of the certification presented, and decide whether it indicates robust quality systems that have been continually monitored and improved as part of a program, or is just based on a single visit by an individual. Beware if a firm presents a certification, and the individual or firm that certified them cannot be contacted, or is not truly independent of the facility being audited. Try to decide if the motivation for such a program springs from a sincere desire for quality improvement, or from a sales perspective. In the latter case, an in-person audit is warranted.

Questions to ask contract manufacturers about certification:

1. What is the authority of the certifying organization? How many firms are currently in their program? How many were added (or removed) in the past year?

2. How is the staff of the qualifying or certification organization trained? Is the training and experience relevant to the operations of interest?

3. How frequent are audits and requalification for the program, and what is the duration?

4. When was the most recent audit and what type of audit was it?

5. How long has the firm been certified by this organization? What is the scope (if any)? When does it expire?

6. What changes and improvements to quality systems were made to obtain the program/certification, or were corrected after the most recent audit?

Firms must also consider conflicts of interest, which can occur because the organization that certifies is paid to do so by the certified firm, and the certifying organization may maintain profit centers for certification activities and associated consulting services. Auditors will vary in their interpretation of the regulations, and can only realistically inspect the operations to which they have access. Conflicts can arise if the manufacturer, or quality department, tries to hide problems from the certifier so as to obtain a clean audit. This is clearly counter-productive from a quality perspective. As in all things related to quality improvement, upper management support and provision of necessary resources are essential to getting the most benefit from any certification program.

Looking for more information about working with contract laboratories to ensure proper product testing? Join us for Workshop: Evaluating and Partnering with Contract Labs on Wednesday, Oct. 5 at 1:30 p.m. at SupplySide West to learn more from Marian Boardley on evaluating and selecting a contract testing laboratory.

And check out the Healthy INSIDER podcast where Boardley covers the true costs of internal vs. external testing of dietary supplements.

Marian Boardley is an independent consultant who manages projects for dietary supplement manufacturers and distributors. She helps clients in the food, drug and dietary supplement industries to implement compliance with dietary supplement, food and other cGMPs (current good manufacturing practices). She regularly trains staff to be ready for FDA inspections, and also writes documentation for quality control (QC), laboratory and manufacturing operations. Boardley was born in Yorkshire, England, and is now a U.S. citizen residing on the Colorado Plateau.

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