ICMR- Good Clinical Laboratory Practices (GCLP)-2008

The document "GUIDELINES FOR GOOD CLINICAL LABORATORY PRACTICES (GCLP)" by Indian Council of Medical Research provides a framework for good clinical laboratory practices in India. The guidelines aim to ensure that medical laboratories involved in clinical research and/or patient care provide quality data, which can be used for health research and patient treatment.

The document emphasizes the importance of infrastructure planning according to the services provided by the laboratory, including reception rooms, specimen collection areas, analytical work areas, and record storage facilities. It also highlights the need for qualified and trained staff, with periodic up-gradation of their skills.

Laboratories are required to maintain a personal file of all technical and non-technical staff employed, which should include information on educational qualification, experience, health information, performance appraisal, training certificates, awards, disciplinary actions, and reference letters.

The guidelines also emphasize the importance of equipment maintenance, calibration, and validation, as well as the use of standard reagents and materials. Specimen collection is considered an important step of good clinical laboratory practice, and laboratories are required to have a primary specimen collection manual containing information on patient preparation, methodology, labeling, handling, transportation, and storage of specimens.

The document also provides guidelines for requisition forms, accession lists, worksheets, and reporting test results. Laboratories are required to maintain a record of specimens rejected prior to analysis and use this data to identify areas for staff training.

Overall, the document aims to promote good clinical laboratory practices in India, ensuring that medical laboratories provide quality data for health research and patient treatment.