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Volume IV - 1.6 Other Information

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Orientation and Training

Food and Drug Administration

DOCUMENT NO.:

IV-01
VERSION NO.: 1.3

Section 1 - Laboratory Orientation

EFFECTIVE DATE: 10/01/2003REVISED: 02/14/2013

Analysts also are to be familiar with proper laboratory administrative and regulatory procedures and observe the safety, waste disposal and quality assurance programs in place for their laboratories.

 1.6.1 Administrative and Regulatory Procedures

The Field Management Directives (FMD), Regulatory Procedures Manual (RPM), and Compliance Policy Guides (CPG) are FDA publications that contain pertinent information such as the laboratory research directives, product recall information, and other statements of FDA regulatory procedures. These on-line manuals can be found on the FDA Intranet site and on the FDA Gold Disk.

 1.6.2 Laboratory Safety

Each laboratory has its own safety and waste disposal programs; the supervisor should give copies of these. Nothing is to be put down the drain unless specified as allowable under the waste disposal program.

Read the general laboratory safety instructions found inORA Lab Manual, Volume III, Section One, "Environmental Health and Safety," and in the laboratory's program. The analyst is to understand all instructions before beginning any training exercise. 

Methods in the AOAC Official Methods of Analysis contain references to safety notes in "Appendix: Laboratory Safety," which identifies hazards and means for avoiding or protecting against them. Review instructions under Equipment and references under the method before beginning the analysis. Also consult the MSDS sheets for safety notes. Safety and cross contamination precautions are used with all chemicals. Special care is to be taken to prevent injury from toxic chemicals, explosions, fires, and corrosive chemicals. Some chemicals or organisms may demand special precautions such as use of protective clothing or use of an enclosed balance.

 1.6.3 Quality Assurance

Each FDA laboratory has a quality assurance program (QAP) tailored to its individual responsibilities within headquarters imposed standards. FDA analysts are to participate in the QAP program, perhaps to analyze a national check sample or by assignment to monitor the performance of an instrument. FDA is implementing a national quality assurance program that is based on the ISO 17025 standard for testing and calibration laboratories.