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Unformatted text preview: Quality System Regulations
S. Laguette ME 128 Fall 2007 October 29, 2007
10/29/07 ME128 1 Quality System Regulations
Good Manufacturing Practices (GMP) / Quality System Regulation (QSR) Introduction Flexibility of the GMP Applicability of the GMP GMP Exemptions Types of Establishments Subject to the GMP The Quality System Regulations
10/29/07 ME128 2 QSR
The regulation requires that various specifications and controls be established for devices; that devices be designed under a quality system to meet these specifications; that devices be manufactured under a quality system; that finished devices meet these specifications; that devices be correctly installed, checked and serviced; that quality data be analyzed to identify and correct quality problems; and that complaints be processed. 10/29/07 ME128 3 QSR
The QS regulation helps assure that medical devices are safe and effective for their intended use. The Food and Drug Administration (FDA) monitors device problem data and inspects the operations and records of device developers and manufacturers to determine compliance with the GMP requirements in the QS regulation. 10/29/07 ME128 4 QSR
The QS Regulation is contained in Title 21 Part 820 of the Code of Federal Regulations. This regulation covers quality management and organization, device design, buildings, equipment, purchase and handling of components, production and process controls, packaging and labeling control, device evaluation, distribution, installation, complaint handling, servicing, and records.
10/29/07 ME128 5 Flexibility of the GMP/QSR
It is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet the quality system requirements. 10/29/07 ME128 6 Flexibility of the GMP/QSR
Manufacturers should determine the necessity for, or extent of, some quality elements and to develop and implement specific procedures tailored to their particular processes and devices. The QSR specifies general objectives such as use of trained employees, design reviews, design validation, calibrated equipment, process controls, etc., rather than methods, because a specific method would not be appropriate to all operations.
10/29/07 ME128 7 Applicability of the GMP
The QS regulation applies to finished devices intended to be commercially distributed for human use unless there is an approved exemption in effect. GMP exemptions are codified in the Classification Regulations 21 CFR 862 to 892. The exemption of most Class I devices from design controls is in section 21 CFR 820.30 (a).
10/29/07 ME128 8 GMP Exemptions
FDA has determined that certain types of establishments are exempt from GMP requirements; and FDA has defined GMP responsibilities for others. Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files ( 21 CFR 820.198) or from general requirements concerning records 21 CFR 820.180. Sterile devices are never exempted from GMP requirements. Medical devices manufactured under an investigational device exemption (IDE) are not exempt from design control requirements under 21 CFR 820.30.
10/29/07 ME128 9 Types of Establishments Subject to the GMP
Remanufacturers Custom Device Manufacturers Contract Manufacturers Contract Testing Labs Repackages, Relabelers, and Specification Developers Manufacturers of Accessories Initial Distributors
10/29/07 ME128 10 Quality System Manual
The guidance manual (http://www.fda.gov/cdrh/dsma/gmpman.html) is arranged as if the reader were starting a new business. That is, as if an entrepreneur were sequentially: 1. obtaining information on GMP requirements; 2. determining the appropriate quality system needed to control the design, production and distribution of the proposed device; 3. designing products and processes; 4. training employees; 5. acquiring adequate facilities; 6. purchasing and installing processing equipment; 7. drafting the device master record; 8. noting how to change the device master records; 10/29/07 ME128 11 Quality System Manual
This manual is arranged as if the reader were starting a new business. That is, as if an entrepreneur were sequentially: 9. procuring components and materials; 10. producing devices; 11. labeling devices; 12. evaluating finished devices; 13. packaging devices; 14. distributing devices; 15. processing complaints and analyzing service and repair data; 16. servicing devices; 17. auditing and correcting deficiencies in the quality system; and, 18. preparing for an FDA inspection. 10/29/07 ME128 12 Quality System
The Quality System (QS) regulation requires that each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured (820.5 and 820.20). The GMP requirements are harmonized with the International Organization for Standards (ISO) 9001:1994 and ISO DIS 13485. The quality system should be an integrated effort -- a total systems approach, to satisfy the particular safety and performance needs of a specific manufacturer, product, and user-market. The quality assurance (QA) activities do not simply consist of inspection and testing spot solutions or "fire-fighting," no matter what the product is or how small the manufacturer. 10/29/07 ME128 13 Quality System
In all cases, quality should be considered at the earliest stages in every significant area that has an effect on the quality, safety, and effectiveness of the device. These areas for the Design Engineer include
product development, design verification and validation, component and/or supplier selection, Labeling including instructions for use documentation, design transfer, process development and validation, pilot production 10/29/07 ME128 14 Quality System
Product design assurance is a QA system which assures that customer needs are determined, and that product design requirements are established and met. The ISO 9000 series of QA standards ranges from basic quality control to very significant design and production systems. ISO 13485 is the current international standard for medical devices. The FDA GMP requirements are slightly more extensive because they include extensive coverage of labeling, and complaint handling.
10/29/07 ME128 15 Quality System
An ideal QA system is composed of an organization that executes a QA program according to documented policy and specifications in order to achieve stated objectives. 10/29/07 ME128 16 Design Controls
Each manufacturer is required by regulation to establish and maintain design control procedures for any class III or class II device, and a selected group of class I devices. The quality level of devices and processes is established during the design phase
assure overall quality, meet customer requirements, meet company quality claims, and comply with the intent of the FD&C Act. The terms "product assurance" and "design QA" are often used to identify the quality system activities related to product design. The QS regulation uses the term "design controls." We will cover more in depth later 10/29/07 ME128 17 Component Selection
Component and raw material specifications developed during the design phase should be well conceived and adequate for their intended purpose. New components or components for an unusual application need to be verified (qualified) for the intended use. Manufacturers shall establish and maintain procedures to ensure their purchased and otherwise received products and services conform to their specified requirements. The manufacturers shall then assess their suppliers, contractors, and consultants based on their ability to meet the established specifications.
10/29/07 ME128 18 Labeling Content
During the design phase, clear and concise printed and/or software labeling are written and reviewed; and the ink substrate and attachment methods for printed labeling are developed. Such labeling is designed to meet customer and regulatory requirements. Instructions For Use
10/29/07 ME128 19 Process Quality
Manufacturing methods and processes to be used should be developed, equipment selected, and processes and methods qualified. For all significant processes such as welding, molding, lyophilizing, sterilizing, and packaging/sealing where the output cannot be fully verified, the qualification should include a full validation of the processes. We will cover more in depth later
10/29/07 ME128 20 Management Responsibility
Management with executive responsibility shall appoint a member of management who will have authority over and responsibility for: Ensuring that quality system requirements are effectively established and effectively maintained; and Reporting the performance of the quality system to management with executive responsibility for review.
10/29/07 ME128 21 Formal and Documented Quality System
The QS regulation requires the manufacturer to maintain various records such as: design history files, (DHF) device master records, (DMR) device history records, (DHR) maintenance schedules and records, complaint files and failed device/component files, audit reports, distribution records, and personnel training records.
10/29/07 ME128 22 Approval of Product
The quality system includes procedures for assuring that all products such as components, packaging, labeling, manufacturing materials, and finished devices have been approved for use
10/29/07 ME128 23 Quality Acceptance Activities
The quality system shall determine that all tests and inspections are performed correctly. Performance Specifications Development of tests, test methods, test equipment 10/29/07 ME128 24 Quality System Audits
Management with executive responsibility reviews audit reports as part of their review of the suitability and effectiveness of the quality system. 10/29/07 ME128 25 Employee Training
It is extremely important to understand the following points with respect to typical quality-related functions. Top management sets the quality attitude for the company. Research and development has primary responsibility for designing quality into the device. Technical services or an equivalent functional group has primary responsibility for documenting the design. Manufacturing, process or "scale-up" engineering has primary responsibility for designing quality into the manufacturing processes. Manufacturing personnel have primary responsibility for producing devices that have the maximum level of quality that can be achieved based on the product and process designs. Quality system personnel have primary responsibility for the program's management, status reports, audits, problem identification, data analysis, etc., as described in the QS regulation and in this manual. 10/29/07 ME128 26 QUALITY SYSTEM MAINTENANCE
Correcting problems or responding to conditions identified by audits, operational analyses, and customer feedback data can result in quality system improvements. 10/29/07 ME128 27 MEDICAL DEVICE REPORTING
Manufacturers, distributors, and initial distributor(s) are required to establish and maintain reports, including the Medical Device Reporting (MDR) reports for serious injuries, death, or certain other adverse incidents. 10/29/07 ME128 28 References
Additional Quality System Information 21 CFR 820 - Quality System The Good Manufacturing Practice (GMP - Quality System Regulation) Final Rule (Federal Register) http://www.fda.gov/cdrh/humfac/frqsr.html http://www.fda.gov/cdrh/fr1007ap.pdf Medical Device Quality Systems Manual: A Small Entity Compliance Guide http://www.fda.gov/cdrh/dsma/gmpman.html 10/29/07 ME128 29 References
Compliance Program 7382.845 - Inspections of Medical Device Manufacturers http://www.fda.gov/ora/cpgm/7382_845/pdf/7382_845. pdf (327 kb) ISO Comparison to the Quality System Comparison Chart: 1996 Quality System Reg vs. 1978 Good Manufacturing Practice Reg vs. ANSI/ISO/ASQC Q9001 and ISO/DI 13485:1996 ISO 9001:2000 and FDA Quality System http://www.medinorma.ch/medtec/downloads/thenewiso134852 003v20emedinorma.pdf 10/29/07 ME128 30 ...
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This note was uploaded on 07/08/2009 for the course ME 128 taught by Professor Laguette,s during the Fall '08 term at UCSB.
- Fall '08