Good Laboratory Practice Guidelines

• Good Laboratory Practice Guidelines are crucial for scientific measurements that affect decisions concerned with life and death issues
• Until recently, sound laboratory practices were not consistently adopted, enforced, or audited
• National and international agencies have developed GLP guidelines for various industries (food, agriculture, pharmaceutical, clinical, environmental, etc.)
• Within the USA, federal agencies such as FDA and EPA have produced GLP regulations that laboratories must comply with
• Maintaining GLP compliance can account for 10-50% of a laboratory's total effort, with a typical level of 25%
• Quality Assurance


  Insuring that chemical and physical measurements are made properly, interpreted correctly, and reported with appropriate estimates of error and confidence levels
• Elements of Quality Assurance


  • Standard Operating Procedures (SOPs)
  • Statistical procedures for data evaluation
  • Instrumentation validation
  • Reagent/materials certification
  • Analyst certification
  • Lab facilities certification
  • Specimen/Sample tracking
• Standard Operating Procedures (SOPs)


  Procedures which have been tested and approved for conducting a particular determination
• Within a student laboratory, the experimental procedures provided in the Lab Manual correspond to the SOPs
• Within a commercial laboratory, SOPs should be available or developed to acceptable standards
• Statistical procedures for data evaluation may have procedural details that are optional and arbitrary, with standards adopted within particular fields
• Regulatory agencies often describe acceptable statistical procedures
• Instrumentation validation


  Objective procedures implemented to continuously assess the validity of instrumental data and establish the continuing acceptable operation of laboratory instruments
• Time-related graphical records of instrument validation procedures are called "control charts"
• If an instrument's performance is outside of the control limits, its use must be discontinued until the problem is fixed and the instrument is recertified
• Reagent/materials certification

  Certification must follow accepted procedures and be adequately documented, with each container labeled with certification information
• Analyst certification

  Acceptable proof of satisfactory training and/or competence with specific laboratory procedures
• For the student laboratory, analyst certification requires satisfactory completion of the first three lab assignments
• Laboratory facilities certification


  Evaluation by an external agency of issues like space, ventilation, equipment, storage, hygiene, etc.
• Student chemistry laboratories are generally evaluated by the American Chemical Society as part of the overall chemistry program approval process
• Specimen/sample tracking

  Maintaining the unmistakable connection between analytical data and the specimen/samples from which they were obtained, including the original source and chain-of-custody
• Specimen refers to the item to be characterized, while sample refers to a portion taken for analysis
• Maintaining specimen/sample tracking is crucial for interpreting data, especially for heterogeneous specimens
• Documentation and maintenance of records

  Maintaining records of specimen/sample origins, chain-of-custody, raw and processed data, SOPs, instrument/reagent validation, analyst certification, etc. to provide documentation for legal challenges
• The general guideline is to maintain records for at least 5 years, but often much longer due to increased litigation
• Accountability

  GLP procedures establish clear responsibility for all aspects of the laboratory processes leading to technical results and conclusions
• This accountability places appropriate pressure on analysts to conduct studies with adequate care and concern, and allows for quicker identification of errors and corrective action