{MDQSM Excerpt - TABLE OF CONTENTS}

MEDICAL DEVICE QUALITY SYSTEMS MANUAL:

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

PREFACE

This manual covers the Quality System regulation and the basic Good Manufacturing Practices (GMP) requirements that all manufacturers and distributors must consider when they plan to manufacture medical devices, including medical device kits, trays or packs, for distribution in the United States. Model procedures and sample forms are also included in the manual to assist manufacturers.

Adherence to the medical device Quality System regulation makes good business sense and also serves public health aims -- two very good reasons for the Food and Drug Administration (FDA) to encourage compliance. However, a prerequisite to complying with a regulation is a clear understanding of its content. Recognizing this fact, the Division of Small Manufacturers Assistance (DSMA) developed this manual to help manufacturers increase their knowledge of medical device GMP requirements and FDA compliance policies. DSMA also uses this manual at quality system workshops conducted throughout the country.

The Quality System regulation outlines the minimum elements of a system for designing and producing a medical device. Manufacturers of medical devices commonly find that their quality needs are broader than these basic elements because of the additional need to meet company quality claims as required by paragraph 501(c) of the Federal Food, Drug, and Cosmetic (FD&C) Act and to meet customer needs and requirements.

The DSMA staff and the Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) provided valuable assistance in preparing this manual.

This manual covers requirements of the Quality System regulation that manufacturers of medical devices must consider when they design devices, or when they manufacture, contract manufacture, remanufacture, process, repack, or relabel finished medical devices intended to be commercially distributed. The manual contains articles that explain the various good manufacturing practices (GMP) requirements such as design controls, process validation, calibration, device master records, component control, etc., along with related topics such as labeling. It also contains examples of forms, procedures, decals, etc. Manufacturers may use this guidance when developing their quality system.

This manual incorporates changes required by the Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992. This manual is an update of HHS publication FDA 91-4179, "Medical Device Good Manufacturing Practices Manual, Fifth Edition."  

Table of Contents:

1. The Quality System Regulation –

   1. INTRODUCTION

   2. FLEXIBILITY OF THE GMP

   3. MANUAL CONTENTS

   4. GMP APPLICATIONS AND EXEMPTIONS

                                                              i.           Exemptions

                                                            ii.           Component Manufacturers

                                                          iii.           Remanufacturers

                                                          iv.           Custom Device Manufacturers

                                                            v.           Contract Manufacturers

                                                          vi.           Contract Testing

                                                        vii.           Repackagers, Relabelers, and Specification Developers

                                                      viii.           Initial Distributors of Imported Devices

2. Quality Systems  -

   1. INTRODUCTION

   2. QUALITY SYSTEM PRACTICES

                                                              i.           Design Controls

                                                            ii.           Component Selection

                                                          iii.           Labeling Content

                                                          iv.           Process Quality

                                                            v.           Management Responsibility

                                                          vi.           Formal and Documented Quality System

                                                        vii.           Approval of Product

                                                      viii.           Quality Acceptance Activities

                                                          ix.           Quality System Audits

                                                            x.           Employee Training

3. QUALITY SYSTEM MAINTENANCE

4. MEDICAL DEVICE REPORTING

2. Design Controls  -

   1. INTRODUCTION

                                                              i.           Coverage

2. QUALITY SYSTEM

                                                              i.           Personnel Training

3. DESIGN AND DEVELOPMENT PLANNING

                                                              i.           Interface

                                                            ii.           Structure of Plans

4. DESIGN INPUT

                                                              i.           Input Checklists

5. DESIGN REVIEW

                                                              i.           Combination Devices

                                                            ii.           Preparation For Reviews

                                                          iii.           Why Design Reviews

                                                          iv.           Types Of Design Review Meetings

                                                            v.           Design Review Requirements

                                                          vi.           End Of Initial Design

6. DESIGN OUTPUT

                                                              i.           Documenting Design Output

                                                            ii.           Acceptance Criteria

                                                          iii.           Design Output Approval

7. DESIGN VERIFICATION AND VALIDATION

                                                              i.           Design Evaluation versus Specifications

                                                            ii.           Software Validation

                                                          iii.           Labeling Verification

8. DESIGN TRANSFER

9. DESIGN CHANGES

10. DESIGN HISTORY FILE

11. EXHIBITS

                                                              i.           Design Input Requirements Procedure

4. Process Validation - 

   1. INTRODUCTION

   2. TERMS AND DEFINITIONS

   3. WHY VALIDATE PROCESSES

   4. WHAT PROCESSES SHOULD BE VALIDATED

   5. TYPES OF PROCESS VALIDATION

                                                              i.           Prospective Validation

                                                            ii.           Retrospective Validation

6. PROCESS VALIDATION STUDIES

                                                              i.           Planning the Process Validation Study

                                                            ii.           Installation and Operation Qualification

                                                          iii.           Process Performance Qualification

                                                          iv.           Product Performance Qualification

7. DOCUMENTATION

8. REVALIDATION

9. REFERENCES

10. FOOTNOTES

4. Personnel  -

   1. INTRODUCTION

                                                              i.           FDA Observations

2. GMP REQUIREMENTS

                                                              i.           Employee Selection

                                                            ii.           Production Personnel

                                                          iii.           Technical Personnel

                                                          iv.           Process Validation

                                                            v.           Quality Assurance Personnel

                                                          vi.           Complaint Handling

                                                        vii.           Management

                                                      viii.           Training Methods

                                                          ix.           Training Indicators

                                                            x.           Audits

3. EXHIBITS

                                                              i.           Employee Training Procedure

                                                            ii.           Employee Training Record

6. Buildings and Environment  -

   1. INTRODUCTION

   2. PERSONNEL TRAINING

   3. BUILDINGS

                                                              i.           Repackers, Remanufacturers, Contract Sterilizers, and Relabelers

                                                            ii.           Contamination Control

                                                          iii.           Orderly Operations

4. ENVIRONMENTAL CONTROL

                                                              i.           General Controls

                                                            ii.           Analyze Operation

                                                          iii.           Specifications

                                                          iv.           Monitoring

5. CONTAMINATION CONTROL

                                                              i.           Personnel Sanitation Practices

                                                            ii.           Prevent Contamination by Hazardous Substances

                                                          iii.           Personal Practices

6. EXHIBITS

                                                              i.           Clean Room and Work Station Procedure

                                                            ii.           Cleaning Procedure for the Aseptic Filling Room

7. Equipment and Calibration  -

   1. INTRODUCTION

   2. EQUIPMENT GMP CONTROLS

                                                              i.           Maintenance

                                                            ii.           Records

3. MANUFACTURING MATERIALS

                                                              i.           Analyze Use

                                                            ii.           Control Use

4. AUTOMATED PRODUCTION AND QA SYSTEMS

                                                              i.           Software Validation Guidances

                                                            ii.           Employee Responsibility and Training

                                                          iii.           Formal Development of Software

                                                          iv.           Commercial Software and Equipment

                                                            v.           Validation of Automated Equipment and Processes

                                                          vi.           Automated Data Collection and Processing

                                                        vii.           Equipment Controls and Audits

5. MEASURING EQUIPMENT CALIBRATION

                                                              i.           Calibration Requirements Equipment Selection

                                                            ii.           Procedures

                                                          iii.           Management of Metrology

                                                          iv.           Calibration Record Schedules

                                                            v.           Standards

                                                          vi.           Calibration Environment

6. AUDIT OF CALIBRATION SYSTEM

7. INTEGRATING MEASUREMENTS INTO THE QA SYSTEM

8. EXHIBITS

                                                              i.           P.C. Board Cleaning

                                                            ii.           Calibration Procedures for Mechanical Measuring Tools

8. Device Master Record  -

   1. INTRODUCTION

                                                              i.           Document For Intended Employees

                                                            ii.           Adequate Information

                                                          iii.           Preparation and Signatures

                                                          iv.           Location of Records

                                                            v.           Record Retention

2. DEVICE MASTER RECORD CONTENTS

                                                              i.           Device Specification

                                                            ii.           Specific Documents

                                                          iii.           Records for In Vitro Diagnostic Products

3. QUALITY SYSTEM RECORD DOCUMENTS

4. WRITTEN PROCEDURES

                                                              i.           Developing Procedures

                                                            ii.           Content of Procedures

5. CHANGE CONTROL

6. EXHIBITS

                                                              i.           Documents That May Appear in a Device Master Record

                                                            ii.           Device Master Record Index

                                                          iii.           Product Specification for a Portable Defibrillator

                                                          iv.           Zener Diode Specification

                                                            v.           Label Example

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