Laboratory Auditing for Quality and Regulatory Compliance | Donald C.

Book

Laboratory Auditing for Quality and Regulatory Compliance

ABSTRACT

Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance.

TABLE OF CONTENTS

chapter I|8 pages

Quality and Auditing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quality Control and Quality Assurance

chapter II|10 pages

NONTECHNICAL PARAMETERS FOR EVALUATION

chapter III|10 pages

TECHNICAL PARAMETERS FOR EVALUATION

chapter IV|2 pages

OTHER AREAS TO CONSIDER

chapter V|4 pages

Communications and Follow-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Closing Conference, Final Report, and

chapter |2 pages

EPILOG

chapter |14 pages

SAMPLE LABORATORY QUALITY AUDIT DOCUMENT

chapter 1|16 pages

GENERAL INFORMATION

chapter 2|4 pages

LAP ESTABLISHMENT, DEVELOPMENT, AND IMPLEMENTATION

chapter 3|11 pages

ACCREDITATION PROCESS

chapter 4|11 pages

MANAGEMENT REQUIREMENTS FOR ACCREDITATION

chapter 5|19 pages

TECHNICAL REQUIREMENTS FOR ACCREDITATION

chapter |2 pages

ANNEX A (NORMATIVE)

chapter |3 pages

ANNEX B (NORMATIVE)

chapter 1|1 pages

AIMS AND OBJECTIVES

chapter 2|1 pages

INTRODUCTION

chapter 3|3 pages

DEFINITIONS AND TERMINOLOGY

chapter 4|3 pages

ACCREDITATION

chapter 5|1 pages

SCOPE

chapter 6|1 pages

THE ANALYTICAL TASK

chapter 7|1 pages

SPECIFICATION OF ANALYTICAL REQUIREMENT

chapter 8|1 pages

ANALYTICAL STRATEGY

chapter 10|1 pages

STAFF

chapter 11|5 pages

SAMPLING, SAMPLE HANDLING, AND PREPARATION

chapter 12|1 pages

ENVIRONMENT

chapter 13|2 pages

EQUIPMENT (See also Appendix B, p. 51)

chapter 14|1 pages

REAGENTS

chapter 15|2 pages

TRACEABILITY

chapter 16|3 pages

MEASUREMENT UNCERTAINTY

chapter 17|1 pages

METHODS=PROCEDURES FOR CALIBRATIONS AND TESTS

chapter 18|4 pages

METHOD VALIDATION

chapter 19|3 pages

CALIBRATION

chapter 20|1 pages

REFERENCE MATERIALS

chapter 21|2 pages

QUALITY CONTROL AND PROFICIENCY TESTING

chapter 22|3 pages

COMPUTERS AND COMPUTER CONTROLLED SYSTEMS

chapter 23|1 pages

LABORATORY AUDIT AND REVIEW

chapter |1 pages

REFERENCES AND BIBLIOGRAPHY

chapter C|1 pages

Other References (ISO Guides and Standards)

chapter |14 pages

D. Useful Website Addresses

chapter |1 pages

QUALITY ASSURANCE FOR RESEARCH AND DEVELOPMENT AND NONROUTINE ANALYSIS

chapter 2|2 pages

INTRODUCTION

chapter 3|2 pages

DEFINITIONS

chapter 4|1 pages

PRINCIPLES FOR MAKING VALID ANALYTICAL R&D MEASUREMENTS

chapter 5|6 pages

ORGANIZATIONAL QUALITY ELEMENTS

chapter 6|17 pages

TECHNICAL QUALITY ELEMENTS

chapter 8|15 pages

EXTERNAL VERIFICATION

chapter |2 pages

ANNEXURE A

chapter |1 pages

ANNEXURE B

chapter |1 pages

ANNEXURE C

chapter |2 pages

ANNEXURE D

chapter |4 pages

ANNEXURE E

chapter 1|1 pages

INTRODUCTION AND SCOPE OF DOCUMENT

chapter 2|1 pages

PERSONNEL

chapter 3|2 pages

ENVIRONMENT

chapter 4|1 pages

VALIDATION OF TEST METHODS

chapter 5|1 pages

UNCERTAINTY OF MEASUREMENT

chapter 6|4 pages

EQUIPMENT MAINTENANCE, CALIBRATION, AND PERFORMANCE VERIFICATION

chapter 7|1 pages

REAGENTS AND CULTURE MEDIA

chapter 8|1 pages

REFERENCE MATERIALS AND REFERENCE CULTURES

chapter 9|1 pages

SAMPLING

chapter 10|1 pages

SAMPLE HANDLING AND IDENTIFICATION

chapter 11|1 pages

DISPOSAL OF CONTAMINATED WASTE

chapter 13|3 pages

TEST REPORTS

chapter |1 pages

APPENDIX B References

chapter |1 pages

APPENDIX C

chapter |1 pages

APPENDIX D

chapter |1 pages

APPENDIX E

chapter |1 pages

APPENDIX F

chapter |1 pages

APPENDIX F (Continued)

chapter |2 pages

INTRODUCTION

chapter |1 pages

RESPONSIBILITIES

chapter 2|1 pages

EPA REGIONS

chapter 3|1 pages

PRIMACY STATES

chapter 2|1 pages

REQUIREMENTS FOR CERTIFICATION OF LABORATORIES

chapter 5|1 pages

PLANS FOR CERTIFICATION OF LABORATORIES

chapter 6|1 pages

PRINCIPAL STATE LABORATORIES

chapter 9|1 pages

PRIMACY

chapter 11|3 pages

OTHER CONSIDERATIONS FOR LABORATORY CERTIFICATION

chapter 13|1 pages

PERFORMANCE ON ROUTINE WATER SAMPLES

chapter 14|1 pages

CHAIN-OF-CUSTODY PROCEDURES

chapter 16|3 pages

CRITERIA AND PROCEDURES FOR DOWNGRADING=REVOKING CERTIFICATION STATUS

chapter 17|1 pages

RECIPROCITY

chapter |1 pages

CRITICAL ELEMENTS FOR CHEMISTRY 1. PERSONNEL

chapter 2|1 pages

LABORATORY FACILITIES

chapter 3|3 pages

LABORATORY EQUIPMENT AND INSTRUMENTATION

chapter 5|7 pages

ANALYTICAL METHODS

chapter 6|9 pages

SAMPLE COLLECTION, HANDLING, AND PRESERVATION

chapter 7|10 pages

QUALITY CONTROL

chapter 8|2 pages

RECORDS AND DATA REPORTING

chapter 9|18 pages

ACTION RESPONSE TO LABORATORY RESULTS

chapter 1|1 pages

PERSONNEL

chapter 2|6 pages

LABORATORY FACILITIES

chapter 4|2 pages

GENERAL LABORATORY PRACTICES

chapter 5|13 pages

ANALYTICAL METHODOLOGY

chapter 6|1 pages

SAMPLE COLLECTION, HANDLING, AND PRESERVATION

chapter 7|2 pages

QUALITY ASSURANCE

chapter 9|24 pages

ACTION RESPONSE TO LABORATORY RESULTS

chapter |1 pages

CRITICAL ELEMENTS FOR RADIOCHEMISTRY 1. PERSONNEL

chapter 2|1 pages

LABORATORY FACILITIES

chapter 3|1 pages

LABORATORY EQUIPMENT AND INSTRUMENTATION

chapter 4|1 pages

GENERAL LABORATORY PRACTICES

chapter 5|5 pages

ANALYTICAL METHODS

chapter 8|1 pages

RECORDS AND DATA REPORTING

chapter 9|11 pages

ACTION RESPONSE TO LABORATORY RESULTS

chapter |5 pages

APPENDIX A

chapter |2 pages

APPENDIX B

chapter |3 pages

APPENDIX C

chapter |2 pages

APPENDIX D

chapter |1 pages

APPENDIX E

chapter |38 pages

APPENDIX F

chapter |22 pages

FEDERAL REGISTER (FDA): GOOD LABORATORY PRACTICE REGULATIONS FOR NONCLINICAL LABORATORY STUDIES