cGMP Food Processing Certification: Audits for Food & Beverage Manufacturers

A cGMP food processing audit is an independent, on-site audit of a food or beverage manufacturing facility against Kiwa ASI's cGMP Food Processing 2.0 standard, a HACCP-based standard founded on FDA's 21 CFR Part 117. It covers three modules (Food Safety Management System, current Good Manufacturing Practices and HACCP) plus a mock recall completed in under two hours. Sites that score 70% or higher are certified, with an audit every year.

Food and beverage manufacturers, co-manufacturers and co-packers, and ingredient manufacturers, typically when a retailer, brand owner or other customer asks for a third-party food safety audit. Warehouses that only store and ship packaged products use cGDP Storage & Distribution, packaging manufacturers use cGMP Food Packaging, and dietary supplement makers use a 21 CFR Part 111 audit.

Allergen management is requirement 2.1.5 in Module 2. The auditor checks how you keep unintended allergens out (including through suppliers, employees and visitors, even if you make no allergenic products), how allergens are received, handled and stored, how changeovers are cleaned and verified by environmental swabbing or product testing where applicable, that allergens aren't stored above other materials, and that allergen labels are accurate and legally compliant. Allergen mislabeling or cross-contamination is a critical nonconformity.

A certification audit takes at least one full day (about 8 hours), and a scope extension audit at least half a day. Audits are planned in half-day increments and quoted during the application, based on the size of your facility and any satellite sites, the number of employees, your product types, processes and HACCP plans, and the scope. Duration is reviewed every year.

Every year. The certificate expires 30 days after the one-year anniversary of your last certification audit, and technical review can run past that date, so schedule the audit early enough to avoid a lapse. Each recertification audit that achieves compliance gives you a new certificate, score, rating and expiration date.

Yes. Kiwa ASI offers optional mock audits: unscored assessments that show compliance gaps before your scored certification audit. A mock audit can't be converted into a scored certification audit once it has started, and during it you need to show at least a mock production run or a walk-through of your process.

70% or higher. Every audit starts at 100%; each minor nonconformity deducts 1%, each major 5% and a critical 100%, so any critical nonconformity fails the audit. Ratings are Excellent (90–100%), Good (80–89%), Complies (70–79%) and Fails (0–69%), and two Excellent ratings in a row earn a Superior rating. Some customers require a higher score than 70%.

Both use the same three modules, mock recall, scoring and certification rules. Food Processing is for food and beverage manufacturers and adds food-specific requirements: a fuller allergen program (allergens defined by law where you sell, receiving and storage segregation, changeover verification by swabbing or product testing, and accurate, legal allergen labels), separate requirements for dry and for temperature- or atmosphere-controlled storage, and product descriptions that record safety characteristics such as water activity and pH, and allergens. Food Packaging is for manufacturers of food-contact and non-contact packaging. Sites that do both can combine the two standards in one certification scope.

No. FDA requires the food facilities it regulates to follow the cGMP requirements in 21 CFR Part 117 and enforces them through inspections, but it doesn't require a certificate. Certification is a voluntary third-party audit, usually requested by customers. The standard itself can't be used in place of FDA, USDA or other regulatory requirements.

No. cGMP Food Processing is Kiwa ASI's own audit standard. It isn't GFSI-benchmarked or accredited, although it draws on best practices from FSMA, Codex Alimentarius, ISO standards and GFSI-benchmarked schemes. If a customer requires GFSI-recognized certification, Kiwa ASI also offers SQF, BRCGS and FSSC 22000 audits.

Version 2.0 took effect January 1, 2026, replacing the version 1.1 program from 2018. It organizes the requirements into three modules, states them in measurable terms and adds or expands management commitment and food safety culture, business licensing, certification integrity, electronic records, allergen management, risk-based zoning and environmental monitoring, one-forward and one-back traceability exercises, and a FSMA Food Safety Plan requirement (3.13). Reports now include unscored section summaries. Scoring and ratings didn't change. See the 2.0 change summary.

Not for storage and shipping at your certified site. Requirement 2.13 covers your storage, receiving and shipping, and a Food Processing certificate also reflects good distribution practices in principle. A nearby satellite site that's a direct extension of your processes and shares your management systems can be added to your scope with Kiwa ASI's approval, which may add audit time. Standalone warehouses and distribution centers that only store and ship packaged products use cGDP Storage & Distribution 2.0.

A clear deficiency that could cause serious illness or death, or any falsification of food safety records. The standard's examples include active or likely contamination of raw materials, work in progress or finished products; anything that would make you start a recall or withdrawal; live rodents in processing areas; allergen mislabeling or cross-contamination; non-potable water used in production or to clean product contact surfaces; equipment out of calibration that could lead to unsafe food; failure to correct a critical limit deviation; and chemicals used improperly.

No. Corrective actions aren't required to receive a certificate, but Kiwa ASI strongly recommends root cause analysis and corrective and preventive action. Findings that aren't corrected can be cited as repeat nonconformities, and auditors can upgrade them, for example from minor to major, at recertification.

At least 60 days of production records. If you can't provide them, Kiwa ASI decides whether to continue or stop the audit based on the records available. Your documented programs, training records, corrective action records and HACCP or Food Safety Plan should also be current and ready before the auditor arrives.

Yes. Your facility must be in production on the audit day, or Kiwa ASI can abort the audit. If the production schedule changes after the audit is confirmed, you can demonstrate a small batch instead, as long as you tell Kiwa ASI in writing before the audit starts and still show every production step. For products that aren't running, the auditor samples historical production records.

During the audit, you trace raw materials one step back to their suppliers and a finished product one step forward to your customers, accounting for 100% of the affected product, in under two hours with the auditor present. The auditor records lot numbers, quantities received, produced and shipped, any rework or recoup, and customer details. It doesn't count as your own annual mock recall, which requirement 2.3.4 also requires.

Yes, where FDA's preventive controls requirements apply. Requirement 3.13 calls for a Food Safety Plan developed and overseen by at least one Preventive Controls Qualified Individual (PCQI) with valid training, plus backup so a trained PCQI is available whenever the facility operates; a HACCP certificate alone doesn't qualify someone as a PCQI. The plan adds process, allergen, sanitation and supply-chain preventive controls to your HACCP system and is verified at least annually.

Tell Kiwa ASI. After a recall, notify Kiwa ASI within 24 hours as well as the regulatory agency, and share your investigation and follow-up so Kiwa ASI can decide whether any action is needed to keep your certificate. A new owner must notify Kiwa ASI within 30 calendar days of the ownership change. If you move, tell Kiwa ASI before the move date: the certificate ends when operations stop at the certified site, and the new site needs its own certification audit.

Cost depends mainly on audit time: at least one day, quoted in half-day increments from your facility size, employees, product types, processes and HACCP plans, and scope. Budget as well for any mock audit, training and facility improvements. Call 1 (800) 477-0778 or request a quote for your site.