2. NASC Audit Program
& State Registrations

3. Why be an Audited NASC Member?
1. Help differentiate your company from others in the market
You receive a 2-year 3rd party certification for meeting NASC cGMPs
You can display the NASC Quality Seal on product labels, literature, website and tradeshow materials

4. Why be an Audited NASC Member?
2. Enhanced marketing support from NASC
We have a new branding focus to promote the value of the NASC Quality Seal
Products with the Seal are featured at tradeshows
Audited members are listed first on

5. Why be an Audited NASC Member?
3. The NASC Quality Seal means different things to different audiences
State regulators recognize the value of the Quality Seal
Consumers use it as a “Good Housekeeping” Seal
Expanded distribution options with key retail outlets

6. What are the Requirements to be Audited?
To schedule an NASC Audit, you must meet these requirements:
Must be in Good Standing – Members’ Accountability Guidelines, dues are current, attend meetings
Labels follow NASC Labeling Guidelines
NAERS up-to-date for product registration, adverse events & usage data
QC Manual/SOPs follow NASC cGMPs (1.6.9)

7. Requesting an NASC Audit
Initial Audits
Contact Ryan Cargo or Erica Critchett
We will work with you towards meeting pre-audit qualification requirements
All initial audits are conducted on-site by an NASC auditor

8. Initial Audits Pre-Audit Qualifications
Unaudited members must meet 4 Criteria before the first audit will be scheduled:
Attend a Training Meeting or web-based training module
Send labels, product literature, brochures, etc.
Enter products and sales data into NAERS
Send Quality Control Manual
A NASC Auditor will review Labels, NAERS, and the QC manual to determine if the company is ready for an on-site audit by an NASC Auditor
We will NOT prequalify a company and schedule an on-site audit unless a member is in compliance

9. Initial Audit Qualifications - Labeling
Prior to scheduling an initial audit, the NASC Auditor will check labels for the following:
Label templates MUST be followed for Feed Supplements and for Dosage Form Animal Health Supplements that will display the NASC Quality Seal
Caution Statements found on the templates must be on the labels of DFAHPs
Additional Cautions are required for specific ingredients per SAC recommendations
Warning Statements must be on the labels
The form, order and verbiage of the information on the NASC label templates may NOT be changed

10. Initial Audit Qualifications - NAERS
Prior to scheduling an initial audit, the NASC Auditor will check NAERS for the following:
Product entry information finalized and signed
Ingredients
Active Ingredients = Guaranteed Analysis for Feeds
Inactive Ingredients = Ingredients for Feeds
Administration tables
Maintenance table is required
Loading table is optional
Label files are uploaded
Sales data is up to date (units per quarter)

11. Initial Audit Qualifications – QC Manual
Your QC Manual SOPs must apply to your scope of operations
Mission Statement, Company Overview & Organization Chart
Production and Process Controls
Document Control
Vendor Qualification
Acceptance Status – raw materials, packaging, labels, finished product
Nonconforming Product
Corrective and Preventive Action
Handling, Storage and Distribution of Products
Labeling and Packaging Control
Identification and Traceability
Complaint Files / Adverse Event Reports
Production Records (manufacturers only)

12. Recertification Audits
Recertification Audits are conducted every 2 years
All recertification audits are conducted on-site
Eurofins will contact you to schedule a recertification audit
NASC provides contact info and certification expiration dates
Eurofins will schedule the on-site inspections a minimum of 6-8 weeks in advance

13. Recertification Audits
Recertification Audits are conducted by Eurofins
Eurofins auditors are responsible for the on-site cGMP inspection
NASC auditors are responsible for the off-site labeling and NAERS review, writing audit reports, and follow-up on Corrective Action Plans
Eurofins auditors are NASC’s “eyes and ears” for the on-site inspections of recertification audits but the interpretation and follow-up to the on-site observations remain the responsibility of NASC auditors

14. Audits – Standards & The On-Site Inspection
Standards = NASC cGMPs (1.6.9)
We have developed one checklist that is the basis for all on-site inspections
NASC cGMP Checklist for Auditors (1.25.2)
One checklist covers manufacturers, repackagers and distributors
Items that do not apply to the company’s scope of operations are marked as “Not Applicable” (N/A)
Whatever you are doing is written down – and – whatever is written down; you are doing

15. Audit Reports
At conclusion of the on-site inspection, the auditor will discuss their findings with the company
(For recertification audits, the Eurofins auditor forwards the Compliance Checklist to the NASC Auditor)
NASC Auditor reviews non-compliant items and writes a Summary Audit Report
Audit Report from NASC is ed to Company
GMP Checklist Items (QC Manual), Labeling & NAERS Observations
The company submits Corrective Actions to the NASC Auditor within 90 days from receipt of report

16. Audit Completion When you pass, you will receive:
Signed letter from your NASC Auditor closing the Audit
NASC Certification for 2 years
NASC Quality Seal graphics files
Display the Seal on:
Labels
Product Literature
Website
Trade Show Materials

17. How much will an Audit Cost?
Audit Fee - $2000 (flat rate)
Travel Related Expenses (hotel, airfare, rental car, etc) – $800 average
Eurofins Auditor travel time costs: $0 - $1100
$125/hour for travel time > 4 hours each way
Maximum $550 each way, cap of $1100 total per audit
Average Total Audit Expenses - $3800
NASC Audits – NASC invoices the company
You pay NASC directly
Eurofins Audits – Eurofins invoices the company
You pay Eurofins, not NASC

18. State Registrations Feed Product Registrations
You must register your Feed Products with each state individually
Each state has its own registration process
If your product is a properly labeled Dosage Form Animal Health Product (non-feed), do not register your product as a feed with individual states.  However…

19. State Registrations Remedies (Dosage Form Animal Health Products)
A small number of states have Remedy Laws:
North Dakota, Oregon, South Dakota, Texas, Virginia, Wyoming
Dosage Form Animal Health Products need to be registered with these states under their Remedy Laws

20. Questions?