GLP Regulations

Created by the U.S. Food and Drug Administration (FDA), Good Laboratory Practice (GLP) ensures the caliber and authority of nonclinical laboratory test results by regulating operating procedures, quality assurance and personnel's qualifications. This not only allows test data to be tracked for reliability, but also assures more accurate data.

Job Positions

• GPL guidelines outline the job description, duties and obligations of each laboratory position, while mandating that the laboratory employ a sufficient number of qualified people to cover all positions. Though GPL does not specify the exact type of qualification or education you must obtain to work in a lab, the guidelines do state that your qualifications--either from education or experience--be well documented.

  Once employed, you must maintain your personal hygiene and health in order to avoid contaminating lab tests. You must also change your clothing as frequently as needed to avoid microbiological, radiological or chemical corruption of any tests or study. If you catch an illness that could compromise the integrity of a test, you must inform your supervisors immediately.

Quality Assurance Unit

• Every lab must establish a quality assurance unit (QAU) to monitor laboratory equipment, methods, practices, records and final reports to assure that GLP regulations are being properly followed. As a member of the QAU, you must send laboratory management written documentation of the lab's performance, any recommendations for improving compliance with GPL and dates of inspection of the lab. It is also your responsibility to make all inspection documents available to the FDA.

  While GLP does not require QAU employees to work full time, the FDA prefers full-time employees. This is to ensure that a second job does not distract from your QAU work.

Standard Operating Procedures

• GLP includes standard operating procedures (SOPs). These written laboratory procedures establish protocol for a variety of activities. They include the following procedures: calibrating and standardizing lab instruments; the inspection, maintenance and testing of equipment; proper responses when equipment fails; methods of analysis; processing, storing, and finding data; and record keeping.

  SOPs also inform QAU on the methods they must employ when carrying out study audits, inspections and reviewing final reports. Though not mandatory, SOPs should be kept close to the instrument they pertain to and not filed away in an office.