GLP

GOOD LABORATORY PRACTICE

Good Laboratory Practice or GLP is a concept that recommends set of principles/procedures to be practiced ensuring the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits. GLP as a practice is applicable to non-clinical studies and processes and not for general clinical studies. Good Laboratory Practice (GLP) as a term is most commonly associated with pharmaceutical industry.

In general, GLP is a process of having quality control system involving the organization-wide processes and activities of non-clinical health and environmental studies, that are planned, performed, monitored, recorded, reported and retained.

ISO 13485 Certification

WHAT ARE THE Benefits of GOOD LABORATORY PRACTICE?

  • Clear flow of traceability through detailed trail right from creation of document till its retention/deletion
  • Better trust in the quality and reliability of laboratory data
  • Improved performance in producing the right results the very first time
  • Increase in overall productivity of the activities involved in laboratory through GLP system
  • Enhanced brand reputation through effective laboratory management
  • Reduced need for re-work
  • Drastic reduction in time spent on investigating non-revenue generating activities/cases

What are the requirements of GOOD LABORATORY PRACTICE?

GLP has two important aspects:

  • Firstly, GLP is a Quality Management System that defines a set of quality standards for study conduct, data collection and results reporting.
  • Second key component of GLP system is Quality Assurance (QA). QA unit acts as an independent internal authority that verifies all written policies and procedures and monitors the same throughout the entire study conduct, analysis and reporting.

Some of the important requirements in the process of GLP implementation are:

  • OECD GLP Principles.
  • Management of resources in terms of personnel and physical infrastructure.
  • Characterization is all about accumulating the knowledge. In non-clinical studies, characterization is about the test item (often a chemical compound) and the test system (often a live animal). GLP requires characterization of at least these two entities.

Who can get GLP certification?

GLP is largely applicable to pharmaceutical industry and also to other non-pharmaceutical agents such as colour additives, food additives, food contamination limits, food packaging, and medical devices.

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