National Animal Supplement Council

Transcription

1 NASC established a Preferred Supplier Program for companies who wish to provide products and services to NASC member companies, including raw materials (ingredients), contract manufacturing (dosage form products and feed supplements), analytical laboratory services and other services such as insurance, business consulting, legal expertise, etc. The goal of the program is to prequalify vendors so that NASC members may accept and use products or services from Preferred Suppliers without additional vendor qualification procedures required under NASC cgmps. There are four categories of NASC Preferred Suppliers: Raw Material Suppliers, Contract Manufacturers, Analytical Laboratories and Service Providers. The qualification procedure includes providing information to NASC on the scope of company operations, quality compliance program certifications, statements and additional documentation specific to the type of supplier, e.g., data sheets for each ingredient a Raw Material Supplier would like to qualify and include in the program. Preferred Supplier Analytical Laboratory Data Sheet All Analytical Laboratories must provide the information requested in this form as part of the qualification procedure for acceptance as a Preferred Supplier by NASC. Any fields not applicable to your company should be completed by entering N/A. Please return copies of the requested certifications and the completed form electronically to Bill Bookout at b.bookout@nasc.cc or mail to: NASC PO Box 2568 Valley Center, CA Contact Bill Bookout at the NASC office ( ) with any questions about the Preferred Supplier Program. Page 1 of 5 NASC 2015

2 SECTION 1. ANALYTICAL LABORATORY INFORMATION GENERAL LABORATORY INFORMATION (COMPANY): MAILING ADDRESS: Advanced Botanical Consulting & Testing, Inc. (dba ABC Testing) 1169 Warner Ave., CITY, STATE, ZIP: Tustin, CA SHIPPING ADDRESS FOR SAMPLES: 1169 Warner Ave., CITY, STATE, ZIP: Tustin, CA WEB SITE: YEARS LABORATORY WAS ESTABLISHED: 2002 SECTION 2. GENERAL LABORATORY QUESTIONS LIST THE PRODUCTS & SERVICES OFFERED BY YOUR LAB: NAME OF INDIVIDUAL FILLING OUT FORM: Full testing service in chemistry, biochemistry, microbiology, toxicology Tom Wu NUMBER OF EMPLOYEES: 46 LIST OF INDUSTRIES YOUR LAB NORMALLY PROVIDES TESTING SERVICES FOR: DOES YOUR LAB DEAL WITH RAW MATERIALS OR FINISHED PRODUCTS: Nutritional supplements, Health Care, Food, Pet food, Cosmetics, Biotechnology Both Page 2 of 5 NASC 2015

3 SECTION 3. LABORATORY EQUIPMENT AND EVIDENCE OF COMPLIANCE IS LAB ISO CERTIFIED YES / NO: IS YOUR LAB CERTIFIED BY ANY OTHER ORGANIZATIONS: In the process of getting ISO certified NIST and AOAC performance proficiency check sample programs and AOAC method validation since 2004 FDA REGISTRATION NUMBER: SPECIFY MOST RECENT LABORATORY INSPECTIONS BY STATE, FEDERAL OR FOREIGN AGENCIES: Visited by FDA 4 times during the company history when FDA investigates some companies, who may or may not be a client of ABC Testing, Inc. Regularly visited by county health agencies, environmental & fire safety authorities. DATE AND RESULTS OF INSPECTION: FDA most recently visited March 2016, county authorities visit annually DATE INSPECTION AGENCY RESULTS OF INSPECTION March, 2016 FDA Just requested reports of 1 customer 2012 FDA Requested reports of 1 customer 2011 FDA Requested reports of 1 company who is NOT a customer of ABC Testing. The company crafted fake report on our letterhead 2007 FDA Requested reports of 1 company who adulterated herbal Viagra with real drug actives in the formula. We warned the customer before they got caught by FDA HOW OFTEN IS YOUR LAB AUDITED / INSPECTED: We were regularly audited by customers. Some came once a year and some once in several years. Internal audit is annually done ATTACH CERTIFICATION DOCUMENTS: ed to NASC earlier Page 3 of 5 NASC 2015

4 SECTION 4. LABORATORY QUALITY ASSURANCE POLICIES DOES YOUR LAB PARTICIPATE IN ANY PROFICIENTLY TESTING PROGRAMS OR COLLABORATIVE STUDIES LIKE AOAC: DESCRIBE YOUR QA POLICIES FOR THE FOLLOWING AREAS OR ATTACH CURRENT GLP/SOP DOCUMENTS IF AVAILABLE:. AOAC and NIST. Certificates ed SOPs on files upon request or available for review during site audit PLEASE BRIEFLY EXPLAIN: INSTRUMENT / STANDARDS CALIBRATION: INSTRUMENT QUALIFICATION: Contracted to OEM annually for service and maintenance Per SOP Annually per SOP Qualification And Validation System Of Equipments And Instruments EMPLOYEE QUALIFICATION: All have degrees BS, MS, PhD in their relevant field. EMPLOYEE TRAINING: DOCUMENT CONTROL: PLANNED AND UNPLANNED DEVIATIONS FROM ESTABLISHED METHODS AND SOPs: RECORD RETENTION: APPROVAL OF TEST DATA: RETEST POLICY: TRACEABILITY CLIENT NOTIFICATION OF QC PROBLEMS / TEST RESULTS: Annually and whenever needed Per SOP Employee Training System RevB Per SOP Document and Data Control Per SOP Control of Nonconforming Sample/Test/Work (OOS/OOT) Per SOP Control of Records Per SOP Document and Data Control Per SOP Control of Nonconforming Sample/Test/Work (OOS/OOT) Per SOP Sample Registration & Retention (Old and 2.5.1) We trace all sample based on Lab# assigned during sample registration. Wendi or our customer service representative will contact client immediately if there is any QC problems/test results. Page 4 of 5 NASC 2015

5 SECTION. 5 SUPPORTING DOCUMENTATION ATTACH ANY APPLICABLE STATEMENTS OR EXAMPLES FOR YOUR LAB EXAMPLES: ATTACHED: YES / NO / N-A SAMPLE OF FINAL TEST RESULTS REPORTING DOCUMENT: SAMPLE SUBMISSION FORM: LAB PERSONNEL EDUCATION & TRAINING STATEMENT: AUDIT CERTIFICATIONS: FACILITY INSPECTION DOCUMENTS: EQUIPMENT AND CAPABILITIES LIST: SECTION 6. ADDITIONAL INFORMATION ADDITIONAL COMMENTS / INFORMATION: SECTION 7. CONTACT INFORMATION CONTACT NAME: Wendi Wang TITLE: President OFFICE PHONE: OTHER PHONE: ; info@abctestinginc.com BY SIGNING BELOW, I CERTIFY THAT THE INFORMATION GIVEN BY ME TO THE NATIONAL ANIMAL SUPPLEMENT COUNCIL (NASC), INC. IS TRUE AND COMPLETE TO THE BEST OF MY KNOWLEDGE. I UNDERSTAND THAT IF THE INFORMATION PROVIDED IS NOT THOROUGH AND COMPLETE, NASC WILL REJECT THE FORM AND RESUBMISSION OF THE FORM WILL BE REQUIRED. 11/05/16 SIGNATURE DATE Page 5 of 5 NASC 2015