FDA's CFSAN LABORATORY QUALITY ASSURANCE MANUAL 2nd Edition is now available on-line. Having an electronic version should increase the ease of distribution and use of the manual. It is in PDF format and represents the current official version (last printed in 1995). Please note that many of the individual chapters, guides, and organizational charts contain out-dated information, particularly with respect to organizational structure, position titles, and names of individuals. We encourage users to make reference to other postings and to the directory available on the Center's website for current information in these areas. The manual is currently undergoing revision guide by guide/chapter by chapter to reflect the current organizational structure, policies, practices and procedures in the Center, as well as facility locations and other information that has changed since the last edition.
| Letter of Transmittal & Table of Contents | (available in PDF, 130 kb) |
| Chapter 1: Introduction | (available in PDF, 341 kb) |
| Chapter 2: Quality Assurance Responsibilities | (available in PDF, 1200 kb) |
| Chapter 3: Overview Laboratory Studies | (available in PDF, 690 kb) |
| Chapter 4: Regulatory Samples | (available in PDF, 1700 kb) |
| Chapter 5: Employee Management | (available in PDF, 659 kb) |
| Chapter 6: Laboratory Safety | (available in PDF, 331 kb) |
| Chapter 7: Equipment and Reagents | (available in PDF, 388 kb) |
| Chapter 8: Animal Facility Barrier Operations | (available in PDF, 431 kb) |
| Chapter 9: Records and Reports | (available in PDF, 774 kb) |
| Chapter 10: Good Laboratory Practice Regulations | (available in PDF, 608 kb) |
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*PDF Readers are available for free from the Adobe Acrobat web site. |
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