NASC Audit Program & State Registrations

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

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 www.nasc.cc

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

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)

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

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

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

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)

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)

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

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

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

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 emailed 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

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

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

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…

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

Questions?