GOOD LABORATORY PRACTICES

•PRESENTED BY: SYEDA MAHNOOR KAZMI

•ROLL NO. SP20PD-47

•SEMESTER: 7th
 DEFINITION

• Good laboratory practices is a quality system concerned with the

organizational process and the conditions under which non-clinical
health and environmental safety studies are
• Planned
• Performed
• Monitored
• Recorded
• Reported
• Archived
 PURPOSE OF GLP

• The principles of GLP is to ensure and

promote safety, consistency, high quality, and
reliability of chemicals in the process of non-
clinical and laboratory testing.
 GENERAL RULES

• Prohibition of eating/drinking
• Use of lab coats
• Familiarity with fire extinguishers
• Correct labelling of the containers.
• Safe disposal of the corrosive and
dangerous products and particles.
• Ensuring sterility and cleanliness.
 1. TEST FACILITY ORGANIZATION & PERSONNEL

 Division of the lab subunits based on techniques used e.g., chemical

unit, instrument unit etc. so it can ensure that even distribution of the
workload and precise allocation of the responsibilities.

 The staff/ personnel must follow all the sops and rules and must
ensure integrity of the data.
 Regular training programs are arranged to update and extend the
skills of both professionals and technician.
 2.QUALITY ASSURANCE PROGRAM
• A QA program assures laboratory management that documented standards for the
quality for facilities, equipment, personnel training, and work performance are being
attained, and
• If not, to identify and report the areas that need improvement to meet those standards.
• It is the documented verification of compliance of study plan to the GLP principle.

3. FACILITIES

• Suitable size location and construction

• Suitable room for diagnosis, treatment, and control of diseases
• Storage rooms for supplies and equipment.
 4. APPARATUS, MATERIALS AND REAGENTS
• Apparatus should be appropriated, cleaned and calibrated.
• Reagents must be of good quality and labelled to indicate identity, expiry and
specific storage instructions.
• It must also mention the manufacturer name.

5. TEST SYSTEM
• Appropriate design, apparatus and conditions to carry out the tests.
• Record of all tests systems ( chemicals, physical and biological) is
maintained. E.g. source, date of arrival and arrival conditions.
 6. TEST AND REFERENCE ITEMS

• Details of all the reference materials required should be kept in a

register.
• It must contain description of material, source, date of receipt.
• Identification information on storage containers.
• Reference material inspected at regular intervals to ensure its quality.
7. SOPS
• Written procedures for a laboratories program.
• Approved SOPs to ensure quality and integrity of the data.
• Routine inspections and maintenance of the equipment.
• Actions taken in response to the equipment failure.
 8. PERFORMANCE OF THE STUDY

• Written approved plan by study directors. It is signed by the officials.

• Content includes
• Title
• Nature
• Purpose of the study
• Reference and test items used
• Date ( approval date, starting date)
• Data generated is recorded accurately.
 9. REPORTING OF THE STUDY RESULTS
• Final reports for each study. Amendments, if any, to be signed by study director.
• Information about test facility and sponsor.
• Description of materials , methods and Results of the study.
• Results should include uncertainties, significance evaluation and conclusion.
• A quality assurance program statement.

10. STORAGE & RETENTION OF RECORDS AND MATERIALS.

• Archiving is defined as the long-term retention of completed data, records or study samples.
• Retention arrangements must be designed to protect data, manipulations thus ensuring
integrity throughout the retention period.
• The access is restricted and controlled.
• The storage conditions should be optimal for these samples.
 CONCLUSION

• Good Laboratory practices gives better image to the company as a

quality producer.
• It provides guidelines for better control and maintenance of
instruments and environmental conditions and preservation of test
records.
• Thus, it helps in assuring the quality and integrity of the product.
THANK YOU.