QUALITY MANUAL

QUALITY MANUAL

Authorized By:

________________________________________________ Chuck Kummeth, Chief Executive Officer/President

________________________________________________ James Hipple, Chief Financial Officer

________________________________________________ Kevin Reagan, Sr. VP Biotech

________________________________________________ Marcel Veronneau, Sr. VP Clinical Controls Division

________________________________________________ Diane Wotta, Sr. Director of Quality and Regulatory Affairs

540308.15

Date: __________________________ __________________________ __________________________ __________________________ __________________________

QUALITY MANUAL

Number: 540308 Revision: 15 Supersedes:540308.14 Section: 1.1 Page: 1 of 1 Revision Date: 7/28/14

SECTION TITLE:

CONTENTS

Section 1 1.1

1.2

1.3

Page 1 Page 2 Page 3, 4

TABLE OF CONTENTS

Table of Contents Quality Policy Company Profile

Section 2 Quality System Requirements:

2.1 Page 5, 6, 7 Management Responsibilities

2.2 Page 8

Quality Audits

2.3 Page 9

Personnel

2.4 Page 10

Design Controls

2.5 Page 11

Document Controls

2.6 Page 12

Purchasing Controls

2.7 Page 13

Identification and Traceability

2.8 Page 14, 15 Production and Process Control

2.9 Page 16

Acceptance Activities

2.10 Page 17

Non-Conforming Product

2.11 Page 18

Corrective and Preventive Action

2.12 Page 19

Statistical Techniques

2.13 Page 20

Labeling and Packaging Control

2.14 Page 21

Material Handling, Storage and Distribution

2.15 Page 22

Records

Page 1 of 22

QUALITY MANUAL Section Title: Quality Policy

Number: 540308 Revision: 15 Supersedes: 540308.14 Section: 1.2 Page: 1 of 1 Revision Date: 7/28/14

R&D Systems Inc. Quality Policy:

R&D Systems is committed to the highest level of quality in the manufacture, sale and support of our products. Product quality, compliance to all applicable regulatory requirements, continuous improvement and customer satisfaction shall underlie all of our efforts in development, manufacturing, advertising, sales, shipping and technical support.

Definitions: Quality: the totality of features and characteristics that bear on the ability of a product to satisfy fitness for use, including safety and performance (? 820.3 (s)).

Quality system: the organizational structure, responsibilities, procedures, processes and resources for implementing quality management (? 820.3 (v)).

Assurance of quality and integrity are the responsibility of:

1. the Chief Executive Officer (CEO), who has responsibility for creation of an atmosphere of high standards;

2. the officers, directors, managers and supervisors, who are charged with development and implementation of quality systems; and

3. each employee, who is responsible for the quality of his or her work and for suggesting quality improvements.

This Quality Manual is the top tier of our documentation system. It provides an overview of our Quality System. It is supported by corporate and division standard operating procedures (SOPs) which represent the second tier of our Quality System documents. Relevant SOPs are listed in this Quality Manual. The third tier of the documentation system consists of manufacturing/testing documents, forms and specifications developed by each operating unit.

Our policies are in conformance with the applicable requirements of the Code of Federal Regulations (21 CFR) Quality Systems Regulations for Medical Devices; ISO 13485 Standard: 2003, ISO 9001 Standard: 2008, the In Vitro Diagnostic Directive 98/79 EC and the Canadian Medical Device Regulations.

Sections of the ISO 13485 Standard which do not apply to R&D Systems are as follows: Section 7.5.1.2.3 - Service activities (Reason: Applicable to equipment) Section 7.5.1.2.2 - Installation activities (Reason: Applicable to equipment)

} Section 7.5.1.3 -

Section 7.5.2.2 - Particular requirements for sterile medical devices (Reason: No claim of Section 7.5.3.2.2 - product sterility) Section 8.2.4.2 - Particular requirements for active implantable devices (Reason: No

implantable devices)

Related Procedures: 540007 Canadian Medical Device License, Establishment License and Quality System Certification 540120 Required Standards Listing, Maintenance and Review 541347 Continuous Improvement

Page 2 of 22

QUALITY MANUAL Section Title: Company Profile

Number: 540308 Revision: 15 Supersedes: 540308.14 Section: 1.3 Page: 2 of 2 Revision Date: 7/28/14

R&D Systems was founded in 1976 in Minneapolis, MN. It is a wholly owned subsidiary of TECHNE Corporation (a holding company with no employees). In July 2014, TECHNE was renamed as Bio-Techne. The stock is traded publicly on NASDAQ's National Market System under the "TECH" symbol. Bio-Techne has two operating subsidiaries: R&D Systems, Inc. (RDSI) and R&D Systems Europe Ltd. (RDSE).

RDSI has two operating divisions: Biotechnology, which manufactures reagents primarily for the research market, and Clinical Controls, which manufactures controls and calibrators for chemistry (Bionostics) and hematology (R&D Systems) analyzers. The Bionostics manufacturing facility, located in Devens, MA is certified to ISO 13485:2003. Their ISO Certificate number is FM547845.

The Minneapolis manufacturing facility is certified to ISO 9001:2008 and ISO 13485:2003. Their ISO Certificate numbers are FM547845 and FM547846, respectively.

In 2005, RDSI purchased BiosPacific, which became a wholly owned subsidiary. BiosPacific is located in Emeryville, CA and consists of a sales force which provides raw materials for development of immunoassay kits. BiosPacific received ISO 9001:2008 certification in 2011. Their ISO Certificate number is FM574663.

In 2011, RDSI purchased Boston Biochem in Cambridge, MA. It became a wholly owned subsidiary.

In 2014, RDSI purchased ProteinSimple and Novus Corp. ProteinSimple manufactures instruments for running Western blots and Novus manufactures antibodies. Both of these businesses complement the existing RDSI product lines.

RDSE in Abingdon, England distributes Biotechnology research reagents and is the European Representative for the Biotech Division. They received ISO 9001:2008 certification in July 2007. Their ISO Certificate number is 951 07 4360. EuroCell Diagnostics, Village de la Metairie Batiment B, 35131 Chartes de Bretagne is the European Representative for the Clinical Controls Division.

RDSE acquired Tocris Holdings Limited in April 2011. Tocris Holding Limited is a Bristol, UK based manufacturer of biologically active chemical reagents. RDSE also has two sales subsidiaries, R&D Systems GmbH, in Wiesbaden, Germany and R&D Systems France in Lille.

RDSI established a wholly owned subsidiary in the People's Republic of China in May 2007. R&D Systems China Co. Ltd. (RDSA) opened its Warehouse and Distribution Center in Shanghai on October 1, 2007 and in Hong Kong in February 2011. RDSA provides products, marketing and technical support to our Asian distributors and directly to major customers. In April 2014, RDSA acquired PrimeGene, which manufactures proteins for sale in China.

Page 3 of 22

QUALITY MANUAL Section Title: Company Profile

Number: 540308 Revision: 15 Supersedes: 540308.14 Section: 1.3 Page: 2 of 2 Revision Date: 7/28/14

R&D Systems' physical plant in Minneapolis currently occupies approximately 600,000 square feet of laboratory, manufacturing, shipping and office space as of July 1, 2014. Bio-Techne Corporation and subsidiaries had 1293 full- and part-time employees as of July 1, 2014.

Bio-Techne Organization

Bio-Techne Corporation (TECH)

Minneapolis, MN No Employees

R&D Systems, Inc. Minneapolis, MN 680 Employees

Novus Biologicals Littleton, CO 75 Employees

ProteinSimple Santa Clara, CA 208 Employees

R&D Systems. Europe Abingdon, UK 67 Employees

Tocris Bioscience Bristol, UK 55 Eployees

RDS Asia Shanghai, PRC 31 Employees

Bionostics, Inc, Devena, MA

102 Employees

Boston Biochem Cambridge, MA 11 Employees

BiosPacific Emeryville, CA 7 Employees

RDS GmbH Wiesbaden, DE 10 Employees

RDS France Lille, FR

2 Employees

PrimeGene Shanghai, PRC 45 Employees

This Quality Manual applies to the manufacturing and distribution operations at RDSI in Minneapolis, MN.

Page 4 of 22

QUALITY MANUAL Section Title: Management Responsibilities

Number: 540308 Revision: 15 Supersedes: 540308.14 Section: 2.1 Page: 1 of 3 Revision Date: 7/28/14

Quality is the responsibility of each employee throughout our organization.

Management is responsible for communicating our Quality Policy to all employees and for ensuring full understanding of, and commitment to, quality. ? The CEO has executive responsibility for the Quality System and is responsible for creating an

atmosphere where quality is the highest priority. ? The Vice-Presidents are responsible for overseeing the development, implementation and

maintenance of the Quality System. ? The Director of Quality and Regulatory Affairs (QC/QA/RA) has been appointed as the

Management Representative by the company president and has responsibility for ensuring that quality requirements are effectively established and maintained in accordance with the appropriate regulations and for reporting on the Quality System to upper Management. ? The Director of QC/QA/RA, the Vice-Presidents CCD and Biotech, and the Quality Assurance (QA) staff are responsible for ensuring that our Quality System is fully maintained and implemented. ? Each director, manager and supervisor is responsible for ensuring that Quality Systems are followed in his or her area. ? Each employee is responsible for following quality systems guidelines and for the quality of his or her work.

Two groups are dedicated exclusively to Quality:

1. Quality Assurance (QA) assists operating departments in the development of quality systems and conducts periodic audits to ensure that those systems are implemented faithfully and effectively. Quality Assurance has the responsibility to: ? identify and evaluate quality-related problems; ? recommend solutions to quality problems and verify that any problems have been resolved (corrective actions); ? initiate actions to prevent the occurrence of quality problems (preventive actions); ? control non-conforming products until corrective action has been taken; ? set quality goals and objectives for the company and develop plans to meet those goals and objectives; ? report to Management on quality-related issues.

The Quality Assurance Department is responsible for quality systems, but implementation of these systems and quality per se is the responsibility of each director, manager, supervisor and employee.

2. Quality Control (QC) inspects and tests products at all stages of the manufacturing process, from raw materials to finished goods. QC Management has responsibility for product release against predetermined specifications. The Biotech QC Departments report to the Director of QC/QA/RA.

The following charts describe the organizational and functional structure of the Company. While the structure and organization of the Quality function varies between the two divisions of R&D Systems, their goals are identical.

Related Procedures:

540009 541138 541614

Management Quality Systems Review Procedure Quality Assurance Organization Quality Planning

Page 5 of 22

QUALITY MANUAL Section Title: Management Responsibilities

Quality Systems Flow Chart

Number: 540308 Revision: 15 Supersedes: 540308.14 Section: 2.1 Page: 2 of 3 Revision Date: 7/28/14

Continual improvement of the quality management system

Customers Requirements

Input

Management responsibility

Resource management

Measurement analysis and improvement

Customer Feedback

Product Realization

Product

Quality Control

Output

Manufacturing Operations

Research and Development

Page 6 of 22

QUALITY MANUAL Section Title: Management Responsibilities

R&D SYSTEMS, INC. Department Organization

Chief Executive Officer/ President

Number: 540308 Revision: 15 Supersedes: 540308.14 Section: 2.1 Page: 3 of 3 Revision Date: 7/28/14

Sr. VP Clinical Controls Division

VP Finance & Chief Financial Officer

VP of Sales & Marketing

Business Development

Quality Control Laboratory

Shipping

Hematology Research

Raw Material Manufacturing

Manufacturing

Product Finishing

Facilities IT

Accounting

Marketing/Sales

Biotech Marketing

Biotech Sales

Technical Service

Technical Service BiosPacific

Sr.Director, Quality and Regulatory

Affairs

(Management Representative)

Sr Director Human

Resources

Sr.VP Biotech Division

Cell Culture Development

Antibody Technology

Bioassay Safety

QA/RA

QC/ Microbiology

Cell Culture

Antibody Development

Antibody and Data Operations

Enzymes

Protein Development

Protein Purification Development

New Technologies Molecular Biology

DuoSet/Multi-Plex Development Conjugation

Stem Cell

Product Support

Biomarker Testing Service

Product Finishing

Farm

Manufacturing Shipping

Effective 7/1/14

Page 7 of 22

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