Frequently Asked Questions – NPA GMP Certification Program
How much does the GMP Certification program cost?
NPA GMP program fees paid include annual NPA membership dues and an annual licensing fee of $1,000 per year for GMP-certified companies.
The fees for the third-party audit are negotiated directly with approved auditing companies and are based on the amount of time involved with conducting the audit and follow-up audit activities, as well as the auditor's travel time and expenses. Currently, the auditors charge $2,000 per 8-hour day, and generally an audit within the U.S. of a small to medium size company with one facility will take an average of 2-3 days. Audits of foreign firms may take longer due to language and document translation issues.
When does my certification expire?
Certification is valid for one year. To maintain their NPA GMP certification status, certified companies must remain active NPA members, comply with all NPA supplier membership requirements, maintain compliance to the NPA GMP standards and terms of certification, pay an annual certification fee, and be re-audited every year.
Does the FDA recognize the NPA GMP certification program?
At this time, the FDA doesn't recognize any third-party certification program nor do they certify companies for GMP compliance. However, in June 2007, the FDA published the final GMP regulation specific to dietary supplements (21 CFR 111). In order to keep the NPA GMP certification program relevant and reflect the highest level of industry good manufacturing practices, the NPA GMP Standard has been revised to include all of the FDA GMP requirements of 21 CFR Part 111 and retains certain requirements from the 2000 version of the NPA GMP Standard that exceed requirements of the FDA GMPs, or reflect best industry practices, and/or are necessary for the evaluation of compliance to the NPA GMP Standard.