cGMP Certification: Food Processing, Packaging & Distribution Audits

cGMP certification confirms that a food facility meets Kiwa ASI's cGMP Audit Program 2.0: HACCP-based standards founded on FDA's 21 CFR Part 117 for food processing, food packaging, and storage and distribution sites. Each audit covers the food safety management system, 15 sections of good manufacturing or distribution practice and the HACCP plan, plus a mock recall completed in under two hours. Sites that score 70% or higher are certified, with an audit every year.

Current Good Manufacturing Practice. "Current" means applying the most up-to-date practices. For human food, FDA's cGMP requirements are in 21 CFR Part 117, Subpart B, which covers personnel, plant and grounds, sanitary operations, sanitary facilities, equipment, processes and controls, warehousing and distribution, and defect action levels. Read more in cGMP vs. GMP.

It's the current version of Kiwa ASI's cGMP and cGDP audit standards, published on October 1, 2025 and in effect since January 1, 2026. It replaced the version 1.1 program from 2018, and certificates issued before 2026 stay valid until they expire. The program has three standards: cGMP Food Processing 2.0, cGMP Food Packaging 2.0 and cGDP Storage and Distribution 2.0. See the 2.0 change summary.

It depends on what your site does. Food and beverage manufacturers use cGMP Food Processing, packaging manufacturers use cGMP Food Packaging, and warehouses that store and ship packaged products use cGDP Storage and Distribution. Sites that do both processing and packaging manufacturing can combine the two cGMP standards. Dietary supplement makers have a separate 21 CFR Part 111 audit.

No. FDA requires food facilities to comply with its cGMP rules and enforces them through inspections, but it doesn't require a certificate. cGMP certification is a voluntary third-party audit, often requested by customers. The standards themselves say they can't be used in place of FDA or USDA requirements.

No. Kiwa ASI's cGMP standards are its own audit programs. They aren't GFSI-benchmarked or accredited, although they draw 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.

FDA's cGMP rules depend on the product: 21 CFR Part 117 for human food, Part 111 for dietary supplements, Part 507 for animal food, and Parts 210 and 211 for drugs. Kiwa ASI's cGMP audits cover human food, food packaging, storage and distribution, and dietary supplements.

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 facility size and any satellite sites, the number of employees, product types and HACCP plans, and the scope. Duration is reviewed every year.

Every 2.0 audit starts at 100%. Each minor nonconformity deducts 1%, each major 5% and a critical 100%, so any critical fails the audit. Ratings are Excellent (90–100%), Good (80–89%), Complies (70–79%) and Fails (0–69%). A certificate is issued at 70% or higher, and two Excellent ratings in a row earn a Superior rating.

A clear deficiency that could cause serious illness or death, or any falsification of food safety records. Examples in the standards include active or likely contamination, live rodents in the facility, allergen mislabeling or cross-contact, non-potable water in production or for cleaning product contact surfaces, equipment out of calibration that could lead to unsafe food, failure to correct a critical limit deviation, and anything that would make the site start a recall or withdrawal.

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.

cGMP audits are annual. The certificate expires 30 days after the one-year anniversary of the last certification audit. Because technical review can run past that date, schedule your audit early enough to avoid a lapse in certification.

At least 60 days of production records; if you can't provide them, Kiwa ASI can decide whether to continue or stop the audit. Your documented programs, training records, corrective action records and HACCP or Food Safety Plan should also be current and available when 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. For products that aren't running during the audit, the auditor samples historical production records.

During the audit, you trace a raw material one step back to its supplier 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. It doesn't count as your own annual mock recall, which the standards also require.

Yes, where FDA's preventive controls requirements apply: requirement 3.13 calls for a Food Safety Plan overseen by a Preventive Controls Qualified Individual (PCQI), and a HACCP certificate alone doesn't qualify someone as a PCQI. Every site also needs a HACCP plan under Module 3, with a HACCP team leader and backup certified through an International HACCP Alliance-approved course.

Yes, with Kiwa ASI's written approval. Certified sites can use the ASI Certification Mark on marketing materials, websites, brochures and displays while they're certified, but not on finished product labels or packaging. You can also order a cGMP banner for your facility.

Cost depends mainly on audit time: at least one day, quoted in half-day increments from your facility size, employees, product types 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.