Recommended Steps to NPA GMP Certification

1. Become a Natural Product Association member and submit separate registration for the NPA GMP Certification Program.
2. Have key personnel attend the Natural Products Association FDA GMP training seminar. Over 1000 people have attended this informative popular seminar, representing over 6500 companies.
3. Use information from the seminar and the NPA Self-Assessment Questionnaire to conduct an internal assessment of current company compliance to the NPA GMP standards.
4. Use results of internal the assessment to conduct a gap analysis to identify areas of non-compliance. Develop corrective action/preventative action plan to address audit finding.
5. For additional GMP resources, order NPA GMP program materials. These are resources that have been developed specifically to assist companies seeking to implement good manufacturing practices and become GMP certified through the Natural Products Association.
6. If desired, hire industry consultant to work with company on conducting internal audit and/or with follow-up activities. (Note: companies cannot use the same industry consultant to perform the GMP third-party audit, even if that industry consultant is one of Natural Products Association's authorized GMP auditors.)
7. Contact authorized third-party auditor six to eight weeks prior to desired audit timeline to request quotes and schedule your audit.
8. Complete third-party audit and all corrective actions, achieving an "A" rating.
9. Once your company achieves an "A" audit rating, the auditor forwards an audit report with his/her recommendation for certification to the Natural Products Association.
10. The Natural Products Association reviews the auditor's report and recommendation. If satisfactory, the association forwards a letter stating the terms of certification and company returns the signed letter with the certification fee.
11. The company's certification term is two years as long as the company maintains compliance to GMPs, remains a Natural Products Association member in good standing, and pays the annual renewal fee. NPA GMP certified companies must be reaudited every two years.
12. Program fees paid to the Natural Products Association include a program registration fee of $250.00 and an annual certification fee of $1,000.00. The cost of the third-party audit is negotiated directly with approved auditing companies and is based on the amount of time involved with conducting the audit and follow-up audit activities, and the auditor's travel time and expenses. Currently, the auditors charge approximately $1,600 to $2,000 per 8-hour day, and generally an audit of a small to medium size company with one facility will take an average of four to five days.