Supplier Qualification
An experienced auditor walks your supplier's floor, reviews their records and signs a written audit report, so your quality unit can qualify the supplier and defend that decision to FDA or your registrar.
"Keep it Simple. Keep it Real."
What you get
A certificate of analysis tells you what the supplier says about a lot. An audit tells you whether the system behind it can be trusted. These are the four things that come back.
Scope, standard, dates, people interviewed, records sampled and every observation graded by risk. It is written to stand in your supplier qualification file and be read by an FDA investigator or a certification auditor.
Approve, approve with conditions, or do not approve, with the reasons. If conditions apply, they are specific enough to verify: which records, which corrective actions, by when.
We review the supplier's responses to the findings and tell you whether they actually close the gap. Most supplier audits fail here, after the visit, not during it.
For programs with several suppliers, a risk-ranked list of who needs an on-site audit, who can be qualified by questionnaire and testing, and how often each should be re-audited.
How It Runs
A call to agree which supplier, which materials or services, and which standard applies. We send the supplier a short pre-audit questionnaire and document request so the day on site is spent on the floor and in the records.
One or two days at the supplier, depending on size and risk: opening meeting, facility walk, records sampling, interviews with the people who do the work, and a closing meeting where every finding is stated before we leave.
The signed report within a week, then review of the supplier's corrective actions. You decide whether to qualify. We tell you what we would do and why.
Scope
The standard follows the product. For dietary supplements it is 21 CFR Part 111, including the component and supplier requirements in Subpart E and the identity testing of dietary ingredients, which a certificate of analysis alone does not satisfy. For OTC and other drugs it is 21 CFR Parts 210 and 211, where §211.84 lets you rely on a supplier's certificate only after you have established that the supplier is reliable. For food it is the supply-chain program in 21 CFR Part 117 Subpart G, which requires an annual on-site audit where a hazard can cause serious harm. For cosmetics it is ISO 22716 and the facility requirements that came with MoCRA, and for ISO-certified companies it is clause 8.4 of ISO 9001 or clause 7.4 of ISO 13485.
Inside that frame we look hardest at the things that cause recalls: how the supplier controls its own suppliers, whether its specifications match yours, how it handles out-of-specification results, change control and whether it would tell you about a change, allergen and cross-contact controls on shared equipment, water systems, cleaning validation, and whether batch records are complete and contemporaneous.
If you are building a supplier program from nothing, start with the 21 CFR 111 compliance checklist or the GMP audit preparation guide, then talk to us about which suppliers to audit first.
Price And Terms
Every engagement is priced in writing after a free 30-minute call and before any work starts. On-site work is scheduled in full days; travel from Salt Lake City is billed at cost, with no markup, after the visit. You own every report and record we produce.
A typical supplier audit is one day on site plus preparation and the report; large or high-risk sites take two. Several audits in the same region can be scheduled on one trip to share the travel cost.
Our supplier audits start at $3,500 for a one-day audit, including preparation, the signed report and review of the supplier's corrective actions. Travel is billed at cost. Large or high-risk sites that need two days cost more, and every audit is quoted in writing before it is booked.
Part of it can. Documents and records can be reviewed remotely, and that is sometimes enough for a low-risk supplier. Where the hazard is serious, or where the regulation calls for an on-site audit, as 21 CFR 117.430 does for certain food hazards, someone has to be in the building. We tell you which applies before you pay for travel.
Usually the company doing the qualifying, because the auditor works for you and the report belongs to you. Some suppliers will share an existing audit report instead; we can review one for you and tell you whether it covers what you need.
A certification audit is done by an accredited body against a scheme and ends in a certificate. A second-party audit is done on your behalf, against your requirements and the regulations that apply to your product, and ends in your qualification decision. A supplier can hold a certificate and still fail a second-party audit, because the certificate does not cover your specification.
It depends on risk. Critical suppliers of active ingredients, components that touch the product, or contract manufacturers are commonly audited every one to three years. Low-risk suppliers can be monitored through performance data and questionnaires. We set the frequency with you and write the rationale down, because an investigator will ask for it.
Your Consultant
Jared Clark, our principal consultant, leads every engagement. He has spent his career in quality systems, FDA liaison work and regulatory affairs for pharmaceutical, dietary supplement, OTC drug, cosmetic and medical device manufacturers, and founded Certify Consulting in 2016. He holds the ASQ Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE) and Certified Pharmaceutical GMP Professional (CPGP) certifications, and has worked through certification and surveillance audits alongside NSF, UL, Intertek, SGS and ANAB-accredited registrars. His full credentials and their verification links are on the About page.
Related Services
Ready before FDA arrives, and an experienced hand in your back room while the investigator is there.
A part-time senior quality and regulatory leader with regular site days, on a monthly retainer.
An independent, qualified auditor runs your internal audit program so findings arrive before your registrar's.
Book a free 30-minute call. Tell us the supplier, the material and the deadline, and we will confirm the fixed fee and the dates in writing.
Or email us at support@certify.consulting