An in-person audit performed by a properly trained auditor has no substitute, particularly where issues of safety, hygiene and personnel practices are indicated; these simply cannot be inspected remotely. But, a supplement brand owner can tell a lot about a firm and its operations by looking at the quality of its records from the comfort of their home office. The following steps can help monitor a contract manufacturer or ingredient supplier, and indicate how frequently on-site visits may be required.

Internet Regulatory Searches

FDA.gov has a trove of information. Has the firm been inspected? What was the outcome, and are regulatory actions pending? Available public data sets include:

Don’t forget to look at local news sources for information on mergers, acquisitions, bankruptcies, name changes, layoffs or other significant corporate events. Search social media, job openings and hiring websites to pinpoint potential staff shortages or rapid turnover in quality control (QC) or senior production positions, as those can be an indication of weak quality systems.

Quality Systems and Documentation Audit

Obtain the table of contents for the firm’s quality manual, or a standard operation procedure (SOP) list. Request specific SOPs and documents for processes critical to the product, plus SOPs for QC operations, deviations, investigations, complaints, testing programs and out-of-specification (OOS) results. Ask for training records for a subset of personnel who worked on the batches in the audit.

Get copies of at least three batch records for products the contract manufacturer has made in the past year or 18 months. Choose the batches to audit; don’t let the contract manufacturer select them. Ensure the audited products have approved product specifications, then create a batch record checklist based on the applicable regulations (for dietary supplements, 21 CFR 111, Subparts H and I) and verify:

After the Audit

It’s important to follow-up and get resolution for any issues found. After the review is complete, make a list of findings and share with the firm. Set an appointment for a review of major findings with the contract manufacturer’s management to go over anything that needs to be clarified, and any subsequent corrections they have made. This can often be done during a conference call. Don’t forget to ask for written evidence of fixes, such as new SOPs, records or other documents. Keep all records of the audit on file, as part of the vendor qualification program.

Request a written response to serious issues, and follow up with an in-person visit to ensure the necessary corrections have been made. After this audit process, a brand can better judge how soon and frequently it needs to visit suppliers.

Marian Boardley (marianboardley.com) 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 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.