NPA GMP certification is based on based upon comprehensive third-party inspections of the manufacturing facilities and GMP-related documentation to verify compliance to the requirements of NPA GMP standards. These audits ensure that all elements of the manufacturing process are reviewed to provide reasonable assurance that appropriate procedures are in place and that processes are sufficiently controlled so that products meet their established specifications for quality, including for identity, purity, strength and composition.
The purpose of the third-party audit is to verify a company's compliance with the requirements of the NPA GMP standards. It also provides an opportunity for the exchange of information between the company and the auditor that will identify areas for improvement required to meet the requirements of NPA GMP standards.
The auditor will inspect all areas of the facilities that are involved with the manufacturing, packaging, labeling, testing, warehousing, and/or distributing of dietary supplements. The auditor will observe the general direction of materials flow through the facility, cleanliness, space requirements, equipment and adherence to procedures. Additionally, the auditor will spend a significant amount of time reviewing required GMP-related documentation. The member supplier must have a qualified representative available to answer the auditor's questions during the on-site audit.
Auditors are responsible for all phases of the audits, including completion of the audit checklist, the audit report, follow-up on corrective actions, and any secondary audits.
A fee will be charged for the audit according to fee schedules submitted by the auditing companies. There will be additional charges to cover the auditor's travel and lodging expenses; these expenses are to be determined by the member supplier and auditing company in advance of the audit.
Communication will occur directly between the auditing company and the member supplier during all aspects of the auditing process following guidelines developed by NPA. Any disputes that cannot be resolved within these guidelines shall be referred to the GMP Advisory Committee for resolution.
At the close of the onsite audit, the auditor will meet with the company representative and discuss any deficiencies or areas of non-compliance. The company and the auditor will establish a corrective action list and timeline to complete the required follow-up action items. The company must complete any outstanding corrective action items within the agreed upon timeline and communicate its progress to the auditor on a regular schedule compliant with the NPA audit protocol. Should a company fail to communicate with the auditor on a timely basis and/or fail to complete the corrective actions within the set timeline, the audit will be closed and an incomplete audit report will be submitted to NPA. Once the audit is closed, the company will have to start the audit process from the beginning to become NPA GMP certified.
During the audit, the auditor will note deficiencies and rank them and assign an internal numerical value to the deficiency, based severity and criticality to the manufacturing process and the potential impact on the finished dietary supplement product. The auditor will use this information as part of his or her overall evaluation and to assign a performance rating. NPA has identified three levels of deficiencies, defined below.
A deficiency that, in and of itself, is not of serious nature. A minor deficiency is one that is a departure from established standards having little bearing on the effective use or operation of a product and is unlikely to reduce the material usability of a product for its intended purpose. Several minor deficiencies, or a combination of major and minor deficiencies may prevent a member supplier from receiving an "A" compliance rating.
A serious deficiency. A major deficiency is one, other than a critical deficiency, that represents substantial non-compliance to, or a violation of, a GMP-mandated requirement, procedure or documentation. Major deficiencies may be sufficient to prevent the member supplier from receiving an "A" compliance rating.
A deficiency so severe that a single critical deficiency is sufficient to prevent the member supplier from receiving an "A" compliance rating. A critical deficiency is one that judgment and experience indicate would result in hazardous or unsafe conditions for individuals using, maintaining, or depending on a product, a deficiency that judgment and experience indicate is likely to result in product recall due to economic fraud, or a deficiency that could result in the distribution of a product that is 1) contaminated or toxic, or 2) constitutes a risk to human health.
Performance Rating System
The performance rating assigned to a company is based on the level of compliance the company exhibits to the NPA GMP standards. The levels of compliance are as follows:
- A member supplier demonstrates excellent compliance with NPA GMPs.
- A member supplier demonstrates good compliance with NPA GMPs, but several significant deficiencies were noted and corrected.
- A member supplier demonstrates fair or poor compliance with NPA GMPs, many deficiencies were noted and corrected; a re-audit of the facility required.
When a company has earned an "A" rating, the audit will be closed and auditor submits his or her audit report NPA. Upon review and acceptance of the audit report, the company will immediately qualify for NPA GMP certification. NPA will send a letter stating the terms of certification. When the company returns the certification agreement letter, signed by an officer of the company, with the certification fee the company is officially certified and the association will provide a GMP certificate and GMP graphic files. NPA will list the company on its GMP certification program web page.
Note: To obtain certification, a member company must be audited under the NPA audit process described above. Compliance with other programs (e.g., ISO) will not be accepted as a substitute for the NPA audit process.
A member supplier has the ability to appeal audit finding or an assigned performance rating. The appeal must be in writing and must address each of the deficiencies and the reasons for the appeal. The written appeal must be submitted directly the GMP Advisory Committee c/o Natural Products Association along with the required fees.
The GMP Advisory Committee will review the appeal within 30 working days and attempt to resolve the issue through discussion with the member supplier and auditing company. If this is not possible, a site visitation will be arranged.
The Advisory Committee's review of any appeal is contingent upon prior payment of a fee to offset the expenses associated with appeal process.