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Principles and General Guidelines of Good Laboratory Practice

Good laboratory practice or GLP is a set of principles envisioned to assure the quality and truthfulness of non-clinical laboratory studies that are planned to support research or marketing permits for products structured by government agencies. The GLP is mostly accompanied by the pharmaceutical industry and the required non-clinical animal testing that must be performed before the approval of new medication products. However, GLP applies to many other non-pharmaceutical representatives such as colour essences, food essences, food contamination limits, food packaging, and medical devices. Before getting into the GLP general guidelines, identify the principles of good laboratory practice.

  • Test Facility Organization and Personnel
  • Quality Assurance Program
  • Facilities
  • Apparatus, Material, Reagents
  • Test Systems
  • Test and Reference Items
  • Standard Operating Procedures
  • Performance of the Study
  • Reporting of Study Results
  • Storage and Retention of Records and Materials
Good laboratory practice is a quality system that covers the organizational procedure and conditions under which non-clinical laboratory studies are planned, performed, monitored, recorded, reported, and archived. GLP helps to ensure the quality and integrity of safety test data submitted to the government for the issuance of research permits. Good Laboratory Practice Training provides an in-depth knowledge of GLP and it is beneficial for the certification as well. Here are some of the important guidelines for implementing GLP.

Personnel: The testing facility manager must nominate a study director before the study officially begins. The person will be in authority of the study's overall management and GLP compliance. A

Quality Assurance Unit (QAU) that is separated or independent from the testing facility organization or administration also was required.

Facility & Equipment: To avoid interference and other disturbances that can jeopardize the study, the testing facility should maintain isolation of operations. Separate places must be:

  • the receipt and storage of the test and control object
  • the mixing of the test and control object with a carrier
  • the storage of the test and control object mixtures
  • the covering of the test systems
All the types of equipment used in the study should be intermittently calibrated and maintained. Records of calibration and maintenance should be saved and made available to operators of the equipment.

Characterization: The following information about each test and control item should be known by those involved in the study:

  • identity, purity, composition, and stability
  • date of receipt, expiry date, and storage instructions
  • quantity received and quantity used
Study Plan or Protocol: The key document for the conduct of the study is the study plan or protocol. It contains instructions on how to conduct the study and a rough plan outlining its many phases. It also contains information on the study's methodology and materials. Before the study starts, the protocol must be approved, reviewed, and discussed. The protocol is first created by the research director, who also discusses its contents with personnel and other study staff. The protocol must then be approved by the research director, who must then sign it with a date after discussion. The protocol must be examined by the QAU, who will determine whether it complies with good laboratory practice, once the study director has given his or her approval.

Standard Operating Procedures: The testing facility should have Standard Operating Procedures (SOPs) for each of its several departments, especially for common tasks. The manager of the testing facility must approve SOPs, and the study director must give permission for any deviations from SOPs.

Final Report: The study director, who develops and approves the report, is ultimately in charge of the final report. The final report's main components are:

  • a complete and accurate explanation of the conduct of the study
  • any deviation from an intended course of action (such as SOP or protocol)
  • scientific interpretation of results and critical discussion
  • GLP Compliance Statement by the study director
Storage of Records: The study director is in charge of making sure that all research-related information is recorded and included in records that are securely kept during the study. After the study, these records, and documents—including the protocol, the final report, and standard operating procedures—will be archived. The testing facility manager must give permission for anyone else to access archived records.

Retention of Records: Depending on national GLP regulations, the necessary storage duration for archived records varies.

sarah francoise

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Global Manager Group is one of the largest business management consulting and training company, offering services to organizations of all nature and sizes.

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