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Recommended Steps to NPA GMP Certification
Become an NPA member and submit separate registration for the NPA GMP Certification Program.
Have key personnel attend the NPA GMP training seminar. More than 1,000 people have attended this informative popular seminar, representing more than 6,500 companies.
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.
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.
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 by NPA.
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 NPA's authorized GMP auditors.
Contact authorized third-party auditor 6-8 weeks prior to desired audit timeline to request quotes and schedule your audit.
Complete third-party audit and all corrective actions, achieving an "A" rating.
Once your company achieves an "A" audit rating, the auditor forwards an audit report with his/her recommendation for certification to NPA.
NPA 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.
The company's certification term is two years as long as the company maintains compliance to GMPs, remains an NPA member in good standing, and pays the annual renewal fee. NPA GMP certified companies must be reaudited every two years.
Program fees paid to NPA include an annual licensing fee of $1,000. 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 $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 2-3 days.
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