CSV with GLP

GLP Standard - Good Laboratory Practice

The GLP standard (Good Laboratory Practice) is a system of norms, rules and guidelines aimed at ensuring the consistency and reliability of laboratory research results. The system has been an approved national standard of the Russian Federation since March 1, 2010 - GOST R-53434-2009.

The main goal of GLP is to ensure that the entire progress of a study can be fully traced and reconstructed. Quality control is called upon to be carried out by special bodies that periodically inspect laboratories for compliance with GLP standards.

The GLP system has been in effect for more than 20 years. Initially, the GLP system of standards was developed and implemented by the American Food and Drug Administration (FDA) in relation to industries using toxic substances in order to eliminate existing inconsistencies in regulatory documentation. GLP standards became mandatory for all companies in the United States, and subsequently in countries exporting their products to the United States. Then, through the efforts of the Organization for Economic Co-operation and Development (OECD), these standards began to spread internationally. In particular, in Germany, GLP requirements are mandatory when developing any new types of chemical products

GLP rules include:

requirements for testing organization
requirements for research personnel
requirements for premises in which tests are carried out and animals are kept
requirements for the quality of animals, the conditions of their keeping and feeding
requirements for laboratory equipment and its calibration
requirements for test and control substances
requirements for the preparation and implementation of a detailed standard methodology for experimental work and the testing procedure
requirements for data registration and report preparation
requirements for testing quality control service
standard experimental techniques
Requirements for validation of computer systems (CS)
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2 – Staff

The quality assurance program should include procedures and practices to ensure that all phases of validation, operation and maintenance of computerized systems meet established standards.

13 - Test laboratory manual:

o) defines procedures for monitoring the use of computerized systems for their intended purpose, ensures their validation, operation and maintenance in accordance with these Rules

15 - Research Director:

h) controls the validation of computerized systems used in the study;

109 - The inspector must check:

b) recording data on the operation, maintenance, calibration and validation of measuring equipment and instruments (including computerized systems);

116 - The inspector must check:

d) documents with registration of previously revised SOPs; e) the existence of SOPs, in particular for: use, maintenance, cleaning, calibration and validation of measuring equipment, computerized systems and environmental monitoring equipment;

118 - The inspector must check:

f) changes in primary data, including data stored in computers, whether there is any ambiguity in previous records, including the reason for the change, the person responsible for the change and the date on which the change was made;

g) identification of data created or stored in a computer, the presence of appropriate procedures to protect this data from unauthorized changes or loss;

h) reliability, accuracy and validation of the computerized systems used in the study;

125 - When conducting a research audit, the auditor should:

f) obtain copies of all documents related to control procedures or integral to the study, including: logbooks, laboratory notebooks, documents, worksheets, printouts of data stored in a computer, etc.; and also, in appropriate cases, verification calculations;