Audits: 3 steps to eliminate ‘blind spots’ and ensure compliance

A “blind spot” has multiple meanings, from clinical to instrument-related, psychological and practical.  The lattermost—practical—is an area in which one fails to exercise judgment. Own label distributors performing contract supplier and/or contract manufacturer audits often have critical blind spots that may result in products not meeting specifications or their quality and safety expectations, leading to recalls of their products or, worse, serious consumer adverse events (SAERs).

A top critical blind spot is proper qualification of suppliers and contract manufacturers, as required by cGMP (current good manufacturing practice) regulations (21 CFR part 111). Qualification plays an important role in determining the level of compliance and measuring the quality system implemented by a supplier or contract manufacturer. Proceeding without thoroughly performing qualification is a critical blind spot that often leads to other blind spots.

Three key steps will help eliminate blind spots including the most evident and common one described above.

Never avoid preparing an effective questionnaire. The questionnaire represents a key initial step in the contract partnership process, meaning it is crucial an own label distributor spend the time and, in the case of limited in-house experience, the money to have a qualified individual prepare such a document. A well-written quality supplier questionnaire based on 21 CFR part 111 that targets key areas of a vendor or contract manufacturer’s quality systems (i.e., grounds and facility, water systems, personnel experience, education, hygiene program, in-processing specifications, testing capabilities/expertise and credible documentation) should provide adequate preliminary information to determine whether a contract manufacturer is a compliant and suitable partner. Having such a questionnaire and then taking the time to carefully and knowledgeably review the responses upon return remains a critical initial step for any own label distributor and should not be avoided. Paying close attention to the responses and how they are provided will also help determine whether an experienced and qualified individual addressed it, as it’s possible a salesperson or even a company receptionist might address it, versus the company’s quality assurance (QA) or quality control (QC) group.

Always “inspect what you expect.” This is a long-used phrase concerning food safety throughout the supply chain and used by large organizations such as McDonald’s Family Restaurants to ensure the food sold to consumers meets the standards of quality, safety and cleanliness expected and advertised. In a Squire Patton Boggs case study of Chipotle’s 2015 food poisoning incident that led to 43 store closures in Washington and Oregon, the importance of supply chain transparency was highlighted. The outbreak of foodborne illness indicated the need to examine the food supply chain more closely. As a result, Chipotle hired a qualified team of consultants to help enhance its food safety and traceability program and implemented a more rigorous audit process. Also in 2015, a routine audit revealed its pork suppliers were not compliant with the level and standard of quality and safety the company’s policy focused on: “Food with Integrity.”

This same practice applies to the supplement industry. Using the questionnaire as a starting point, the own label distributor should create a proper and thorough audit plan and perform a physical onsite inspection of the supplier or contract manufacturer, distinguishing this from a casual “visit.” Utilize the questionnaire as a guide to follow up on the responses provided and to avoid overlooking key areas. The own label distributor should carefully note whether the responses of the supplier or contract manufacturer are evident and functional during the audit. And remember, always “inspect what you expect.”

Manage the supplier and contract manufacturer process from ingredients to finished products. When the raw ingredient or finished product arrives, what is the likelihood it is the correct item or it was manufactured under the required regulations? What confidence or assurance of expectation is in place? This is an area own label distributors tend to overlook.  Because no quality system is perfect, active involvement by the own label distributor in every aspect of the product’s lifecycle is vital. Managing and mitigating risks that may arise throughout each process from ingredients to finished products will likely ensure a more compliant outcome for the product and will certainly identify any early issues in-process and prior to product distribution, thus minimizing and, in some cases, eliminating the introduction of a non-compliant, adulterated or unsafe product entering commerce. With the own label distributor’s name prominently on the label, FDA expects full accountability of cGMPs relative to the products’ processing and distribution. Review of recent and past FDA warning letters to dietary supplement own label distributors will repeatedly demonstrate FDA’s enforcement position on this. As such, the need for full compliance should be a driving factor for own label distributors to pay closer attention to their contract partners and avoid blind spots by taking responsibility of managing the oversight of their product processes.

Heather Fairman is an experienced industry subject expert and an independent consultant with EAS Consulting Group LLC. She also serves as technical advisor for the SIDS DOCK Island Women Open Network (IWON), an intergovernmental organization of Small Island Developing States (SIDS). With almost 30 years of combined quality assurance (QA)/quality control (QC) and regulatory experience gained from FDA-regulated industries, Fairman applies her regulatory perspective and approach toward handling FDA matters and compliance requirements relative to all aspects of cGMP (current good manufacturing practice) and development of contract partnerships to ensure mutually beneficial and compliant outcomes.

Looking to know more about the regulatory responsibilities of a contract manufacturing partnership? Join us for the "Managing Quality in a Contract Manufacturing Partnership" workshop on Saturday, Nov. 10, at SupplySide West 2018. This workshop is underwritten by Sora Laboratories.

And for information on FSMA timelines and rules along with current data on FDA’s enforcement efforts and findings, join us for the "Are You Prepared for a FSMA Audit?" workshop on Thursday, Nov. 8. This workshop is underwritten by Venable.