MeriCal Quality Profile

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Adelia Summers
8 years ago
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1 January 5, 2015 Dear Valued Customer, Since the implementation of new federal regulations, MeriCal Inc. has received a large volume of questionnaires and surveys regarding our services and procedures. Many of the questionnaires ask questions and request information addressing very similar issues. Unfortunately, we are not able to complete each customer s individual form as this can be very time consuming and redundant. Therefore, to expedite this information to our customers in an efficient manner, MeriCal assembled all of the pertinent information into a comprehensive format to issue to our valued customers. We are confident that this company profile will successfully provide all of the information requested to our customers. Using this form of response to surveys and questionnaires, allows MeriCal to respond quickly and efficiently to all requests and insure the information provided is consistent in all cases. To assure that all the information requested by our customers is addressed, we ask that you review the information provided and let us know if any additional information is required. MeriCal hopes that you will find this a helpful and beneficial way to share information and provide our customers with excellent service. Thank you for understanding as we value your continued support and interest in our products and services. Sincerely, Steve Nering Vice President Quality Assurance MeriCal, Inc. Manufacturing Complex 233 E. Bristol Lane Orange, CA (714) Packaging Center 2995 E. Miraloma Ave. Anaheim, CA (714)

Unfortunately, we are not able to complete each customer s individual form as this can be very time consuming and redundant.

2 Facility Overview Manufacturing, Technology, and Packaging Complex 233 E. Bristol Lane, Orange, California CA Department of Toxic Substances Control EPA ID# CAL U.S. FDA Food Facility Registration# MeriCal s Corporate Office, Manufacturing and Specialty Packaging Facility in Orange Approximately 98,000 square feet: Manufacturing 45,000 sq. Feet Packaging 20,000 sq. Feet Warehouse 20,000 sq. Feet Office 8,000 sq. Feet Analytical Lab 2,000 sq. Feet Research & Development 3,000 sq. Feet Bottling, Blister, and OTC Packaging Center 2995 E. Miraloma Avenue, Anaheim, California CA Department of Toxic Substances Control EPA ID# CAD U.S. FDA Food Facility Registration# MeriCal s Flagship Bottling Plant in Anaheim Approximately 92,000 square feet: Warehouse 38,000 sq. Feet Packaging 40,000 sq. Feet Office 14,000 sq. Feet Employees Total employment: (All facilities) 370 QA/QC/Regulatory 35 Engineering 20 R&D 10 Manufacturing 85 Packaging 170 Administration 50 Capabilities Manufacturing Packaging - Granulations - Bottling - Powders - Blister Pack - Tablets - Stick Packs - Capsules - Packets - Chewables - Pouches

FDA Food Facility Registration# 10430778510 MeriCal s Corporate Office, Manufacturing and Specialty Packaging Facility in Orange Approximately 98,000 square feet: Manufacturing 45,000 sq.

3 Certifications and Quality 1 Food & Drug Administration U.S. Department of Health & Human Services o Registered Drug Establishment Facility Establishment # o Registered Drug Establishment Facility Establishment # State of California Board of Pharmacy o Manufacturer of Dangerous Drugs o Registered Representative License, Drug Wholesaler (8/1/2015) o Manufacturer of Dangerous Drugs o Registered Representative License, Drug Wholesaler (3/1/2015) 3 State of California Department of Public Health Food & Drug Branch o Drug Manufacturing License #41441 (11/9/2015) o Organic Processed Product Registration #16482 (1/7/2016) o Processed Food Registration #16482 (1/7/2016) o Drug Manufacturing License #23417 (10/3/2016) o Organic Processed Product Registration #23417 (8/26/2015) o Processed Food Registration #23417 (8/26/2015) o Pet Food Production License #23417 (6/30/2015) 4 Health Canada Natural Health Products Directorate o Foreign Site Reference Number o Foreign Site Reference Number NSF International o GMP for Sport #C issued 1/01/2015 o GMP Requirements in NSF/ANSI 173, Section 8 o Initial Certification #C issued 6/2/2011 o GMP for Sport #C issued 1/01/2015 o GMP Requirements in NSF/ANSI 173, Section 8 o Initial Certification #C issued 6/02/2011

Pharmacy o Manufacturer of Dangerous Drugs o Registered Representative License, Drug Wholesaler (8/1/2015) o Manufacturer of Dangerous Drugs o Registered Representative License, Drug Wholesaler

4 6 UL (formerly STR-Registrar) Certificate of Conformance o Registration Number o Certificate Issue Date: 4/23/2014 o Issue Number: 1 o Expiration Date: 9/27/2016 o Registration Number o Certificate Issue Date: 4/23/2014 o Issue Number: 1 o Expiration Date: 9/27/ Quality Assurance International (QAI) o Handler (Processor) o Certificate of Compliance (# A) o Certified Organic (effective 8/8/2008) 8 OneCert International o Certificate of Compliance (#ONE H-NOP) o Certified Organic (effective 5/20/2010) Recent Government Agency Inspections State of California Department of Public Health Audit performed in Orange Manufacturing facility 10/3-10/7/2013 o Initial review of OTC processes and procedures o No violations or observations cited o Drug Manufacturing License issued U.S. Food and Drug Administration Audit performed in Orange Manufacturing facility 2/25-2/27/2013 o Review of compliance with 21 CFR Part 111 cgmp s o No violations or 483 Form Issued o No warning letters or recalls in past 5 years State of California Department of Public Health Audit performed in Orange Packaging facility on 3/20/2012 o (2) minor facility observations noted and immediately corrected o Performed Semi-Annually o No Warning letters or recalls in past 5 years

Certified Organic (effective 8/8/2008) 8 OneCert International o Certificate of Compliance (#ONE-754-130320-H-NOP) o Certified Organic (effective 5/20/2010) Recent Government Agency Inspections State

5 Quality Assurance Orange Manufacturing and Packaging Products are manufactured by MeriCal and are held, packaged, and/or distributed here; other materials are shipped from customer for contract packaging services. Anaheim Packaging Facility Many products packaged are manufactured in MeriCal s Orange manufacturing facility; other materials are shipped from customer for contract packaging services. General Requirements Separate areas for different operations Cross contamination control Safety Program GMP training program MSDS available to your employees Proper uniforms/gowning in production areas Job descriptions General Sanitation Humidity control Temperature control Water purification system Pest Control SOP documenting pest control procedures Internal or external licensed applicator Applicators license on file Proper storage of pesticides Map of facility indicating trap, bait stations, etc. List of approved pesticides and MSDS Formal contract with outside Service Documented Scheduled Inspection Corrective Action Response

Anaheim Packaging Facility Many products packaged are manufactured in MeriCal s Orange manufacturing facility; other materials are shipped from customer for contract General Requirements Separate

6 Receiving & Warehouse A written cleaning program A quarantine area Materials segregated Materials properly identified Rejected materials identified and controlled via written procedures Records on receipt of your raw materials SOP for Receiving and Warehousing SOP for sampling Manufacturing SOPs for different operations SOPs available to operators A product rework procedure Equipment cleaning and use logs Equipment maintenance logs A documented equipment calibration program Water hoses properly stored to prevent contamination Batch production and control records Raw materials inventory tracking Master production and control records Materials & equipment identified throughout process Equipment cleanliness identifiable Packaging SOP for line set-up and approval SOPs available to operators SOP for product sampling Equipment cleaning and use logs Written procedures outlining in-process controls Spatial or physical separation between lines Components inspection program Product reconciliation

and use logs Equipment maintenance logs A documented equipment calibration program Water hoses properly stored to prevent contamination Batch production and control records Raw materials inventory

7 Label control and reconciliation Equipment identified Packaging lines identified Analytical Lab Raw materials testing program Raw material test results compared to vendor's COA In-process testing Finished product testing Raw material and product specifications Packaging component specifications QC samples identified and retained Raw material and product test records Assay methods validated Instrument calibration and maintenance program Lab standards program Reagent control program to assure potency Microbiological Lab Written cleaning and sanitizing procedures Periodic instrument calibration Autoclave validation Stock Culture Maintenance program Exposure plate controls Positive and negative controls Media growth promotion

test records Assay methods validated Instrument calibration and maintenance program Lab standards program Reagent control program to assure potency Microbiological Lab Written

8 Stability Program Stability Failure Documentation Methods are Stability Indicating Stability protocols consistent with industry standard Stability rooms validated for temp and RH control Temperature/ humidity monitored daily or by chart recorder Annual Stability Program SOP defining program Failure Investigations SOP for failure investigations SOP for Out Of Specification test results Quality Assurance Separate QC and QA departments (Quality Unit) Quality Unit a separate group from Operations SOPs for monitoring critical unit operations Perform Quality Standard Evaluation (trend studies) Finished product retain program Internal Audit program Vendor Certification program Batch record review and retention SOP for complaint handling

Specification test results Quality Assurance Separate QC and QA departments (Quality Unit) Quality Unit a separate group from Operations SOPs for monitoring critical unit operations

Pharmaceutical Wholesaler Site Inspection Checklist

Pharmaceutical Wholesaler Site Inspection Checklist Date and time of inspection: Legal business name and plant name: Location (address): Phone number: Fax number: Email address: Web site URL: Contact Person: