August 31, 2017
Audit—the word can strike fear into even the most confident organization, as it generally means the spotlight gets turned on, and the magnifying glass comes out. Unfortunately, being subject to an audit often has a negative connotation, as a dietary supplement contract manufacturer must be ready to show what it is made of. For a dietary supplement contract manufacturer, this can mean a detailed examination of any or all aspects of the manufacturing process by either a customer or regulatory body. A reputable contract manufacturer, however, recognizes every audit as a chance to shine—to show it is always audit-ready, and that excellence is the norm, not the “audit only" exception.
While the goal is the same for both groups (customer or regulatory body)—to make sure a contract manufacturer is following all applicable regulations—each group has a specific agenda and looks for different things. Customers often have their own set of quality standards they expect their CM to follow, in addition to industry standards. A customer may review various items, such as recent customer complaints, staff proficiency, equipment logs, regulatory oversight and housekeeping/environmental procedures, in addition to reviewing batch records for consistency. From a customer’s perspective, a contract manufacturer is an integral part of the product and brand strategy, as a poor-quality product can adversely affect a brand’s reputation. Additionally, as a marketer, the brand holder is ultimately responsible for its product’s success and failure, regardless of the contract manufacturer’s role. For this reason, a customer audit is an integral step in assuring product quality throughout the manufacturing process and instilling confidence that its branded product meets every expectation.
Similarly, a regulatory body such as FDA, Therapeutics Goods Administration (TGA) or third-party auditing firm such as NSF International or National Animal Supplement Council (NASC) will conduct inspections to ensure compliance with regulations, as well as consumer safety. When a contract manufacturer doesn’t maintain its set standards, it can adversely affect the quality its certifications convey to marketers and consumers. These audits can take several days and examine many aspects, such as staff qualifications, equipment conditions and maintenance, cleaning procedures, standard operating procedure (SOP) review, testing procedures (including an examination of the lab), and a close examination of how suppliers are chosen and qualified. Every aspect of how a contract manufacturer does business can affect overall quality and is subject to scrutiny. And, since contract manufactures aren’t required to seek certification by a third-party certifying body, when they are willing to rise to this level of scrutiny, it represents an added layer of protection for marketers and consumers.
In terms of consumer safety, FDA recently took an interest in how dietary supplement manufacturers source ingredients, by shifting its focus from responding to contamination to preventing it. Although customer and certification audits routinely check the validation of suppliers, going forward, FDA, as part of the Food Safety Modernization Act (FSMA), requires all dietary supplement manufacturers have a supplier/foreign supplier verification program (FSVP) in place. This means dietary supplement manufacturers must implement supplier verification procedures, determine which supplier verification activities will be conducted, conduct the activities outlined in their determined program, use approved suppliers and finally, document supplier verification activities.
Although setting federal guidelines for dietary supplement manufacturers is a commendable first step in increasing the safety and transparency of sourced ingredients, an audit is still a necessary endeavor to ensure all guidelines are being followed appropriately. Customer and certification audits serve a valuable purpose in setting standards for quality, but are often limited by the exclusive scope of a specific product, ingredient or intended customer base. Ideally, an audit should be able to identify and verify all critical aspects of the manufacturing process and the facilities involved. Imagine an overarching audit that identified and set all critical standards necessary for ensuring the safety and efficacy of dietary supplement manufacturing. Currently, the Global Retailer and Manufacturer Alliance (GRMA), in partnership with NSF, is working to develop American National Standards Institute (ANSI) approved standards for the dietary supplement industry. These audits will examine cGMPs (current good manufacturing practices) in manufacturing, packaging, labeling and holding operations for dietary supplements. Aimed at inclusivity, passing an ANSI audit would signify that no stone has been left unturned, and the dietary supplement manufacturer meets/exceeds all applicable regulations for safety and quality. ANSI standards would also provide dietary supplement manufacturing customers with an alternative to conducting their own costly and time-consuming audits, with manufacturers being able to readily provide documentation of recent ANSI audits.
Ultimately, the goal of a dietary supplement manufacturer should be to create safe and efficacious products. Verification of quality and safety standards through an audit will always be a necessary step in assuring the public that a contract manufacturer is worth its salt. However, an audit shouldn’t be viewed as a negative, but instead a positive opportunity to continually strive to be the best in the industry—making quality a way of life.
Looking for ways to establish and maintain a successful contract manufacturing partnership? Join us for the Achieving a Successful Contract Manufacturing Partnership workshop on Friday, Sept. 29, at SupplySide West 2017. The Workshop is underwritten by Elite One Source, Fortif Bio and Sora Laboratories, LLC.
Laura Willis is the director of quality assurance (QA) for National Enzyme Co. (NEC, nationalenzyme.com). She has a master’s degree in biology from Missouri State University, emphasizing microbiology and immunology. With more than 15 years of experience working in microbiology, in addition to her years overseeing the quality control (QC) process, Willis’ extensive background makes her a valuable asset.
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