GLP Principles and Objectives

GLP Principles

• Provides a framework for laboratory studies to be planned, performed, monitored, recorded, reported, and archived
• Governs nonclinical studies conducted to evaluate the safety or efficacy of chemicals (including pharmaceuticals)

GLP Objectives

• Ensures regulatory authorities that the data submitted is accurate
• Ensures that the data submitted is an accurate representation of the study's findings
• Ensures that data can be traced
• Promotes test acceptance on a global scale

GLP Components

• Archiving of records
• Apparatus, material, and reagent facilities
• Quality assurance programs
• Performance of the study
• Reporting of study results
• Standard operating procedures (SOP)

GLP Principles

• GLP provides a framework for laboratory studies, including planning, performance, monitoring, recording, reporting, and archiving
• GLP governs nonclinical studies evaluating the safety or efficacy of chemicals, including pharmaceuticals
• GLP ensures data accuracy and traceability, promoting global test acceptance

Mission of GLP

• Archiving of records
• Apparatus, material, and reagent facilities quality assurance programs
• Performance of the study
• Reporting of study results
• Standard operating procedures (SOP)

Organization and Personnel

• Each individual involved in nonclinical laboratory studies must have necessary education, training, and experience
• Each testing facility must keep a current summary of training and experience, as well as a job description, for each person involved or supervising the study

Quality Assurance Unit

• A testing facility must have a quality assurance unit that monitors each study to ensure compliance with regulations
• The unit ensures facilities, equipment, personnel, methods, practices, records, and controls are in accordance with regulations

Facilities

• Each testing facility must be of suitable size and construction to facilitate proper conduct of nonclinical laboratory studies
• The facility must be designed to prevent any function or activity from having an adverse effect on the study
• Required facilities include:
  • Animal care facilities
  • Animal supply facilities
  • Facilities for handling test and control articles
  • Laboratory operation areas
  • Specimen and data storage facilities

Equipment

• Equipment design must be appropriate and of adequate capacity
• Equipment maintenance and calibration require:
  • Written standard operating procedures
  • Written records
  • A log book
  • Ensuring equipment is fit for use