Good Laboratory Practice (GLP) — a system of requirements for organizing, planning and carrying out preclinical (non-clinical) studies of substances or drugs, the documentation of the results and the quality control of these studies.

The aim of Good Laboratory Practice is to guarantee the reliability and accuracy of the data obtained in preclinical studies and to ensure environmental protection.

The basic principles and requirements of Good Laboratory Practice include:

• Quality management: Laboratories conducting preclinical research are required to have quality management systems (German translation: Qualitätsmanagementsysteme) in place, including standardized procedures, documentation and staff training. These systems ensure compliance with GLP guidelines.
• Logs and standardization: A log should be kept for each test or experiment in which the methodology of the test or experiment is described in detail. All methods and procedures must be standardized and documented.
• Equipment and facilities: Laboratories must have the equipment (German: Ausrüstung), instruments and materials required to carry out research. This equipment must be regularly maintained, calibrated and checked.
• Staff and training: Laboratory staff must be qualified and trained in accordance with GLP requirements. All training courses (translation into German: Schulungen) must be documented.
• Documentation and reporting: All phases of research must be documented accurately and in detail. This includes records of logs, data, equipment, staff and other information necessary for the reproducibility of results and confirmation of their reliability.
• Data storage and archiving: Data and records should be stored securely and be available for inspection and review for a certain period of time after completion of the study.
• Inspections: Laboratories may be subject to regular inspections and audits by the competent authorities (German translation: zuständige Behörden) to ensure compliance with GLP guidelines.
• Protecting the rights and welfare of animals: When animals are used in research, animal welfare and protection standards must be observed. Mutual recognition of test data means that a lot of animal testing can be avoided.

Good Laboratory Practice is widely used in the pharmaceutical, biomedical, chemical and research industries. It is intended to ensure the reliability of data obtained in laboratory research and to support the safety and reliability of new products and technologies before they can be tested on humans or brought to market.

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