LME Assignment

∆ LME Assignment 1

1) What is GLP? [2]

=>Good Laboratory Practice (GLP) is a set of quality assurance principles ensuring the consistency, reliability, and integrity of non-clinical laboratory studies, essential for regulatory compliance in research and development.

2) Discuss the benefits of GLP. [2]

=>Good Laboratory Practice (GLP) offers several benefits in research and development:

i. Data Integrity: GLP ensures the accuracy, reliability, and consistency of data, fostering confidence in study outcomes and supporting informed decision-making.

ii. Regulatory Compliance: Adhering to GLP standards is crucial for regulatory approval, demonstrating that studies are conducted with high quality and in compliance with established guidelines.

iii. Traceability and Reproducibility: GLP emphasizes thorough documentation, enabling easy traceability of procedures and facilitating the reproducibility of experiments, enhancing the scientific validity of results.

iv. Risk Management: By implementing systematic protocols, GLP helps identify and manage potential risks early in the research process, minimizing errors and ensuring the safety of personnel and the integrity of the study.

In summary, GLP not only safeguards the integrity of data but also streamlines processes, enhances regulatory acceptance, and contributes to the overall reliability of scientific research.

3) Why is NABL accreditation important? [2]

=>NABL (National Accreditation Board for Testing and Calibration Laboratories) accreditation is crucial for two primary reasons:

i. Quality Assurance: NABL accreditation ensures that a laboratory complies with international standards, indicating its commitment to maintaining high-quality testing and calibration practices.

ii. Credibility and Acceptance: Laboratories with NABL accreditation are recognized for their competence and reliability, facilitating acceptance of their test results nationally and internationally, fostering confidence in the data they generate.

4) Name few international accreditation boards. [2]

=>•International Laboratory Accreditation Cooperation (ILAC)

•International Organization for Standardization (ISO)

•National Association of Testing Authorities (NATA)

•UK Accreditation Service (UKAS)

•The American Association for Laboratory Accreditation (A2LA)

•The Asia Pacific Laboratory Accreditation Cooperation (APLAC)

•The Pacific Accreditation Cooperation (PAC)

5) Discuss the principle on reporting of study results in GLP. [2]

=>The Principles of Good Laboratory Practice (GLP) are a managerial quality control system covering the organisational process and the conditions under which non-clinical health and environmental studies are planned, performed, monitored, recorded, reported and retained (or archived).

6) What is the aim of laboratory accreditation? [2]

=>•Accreditation is a good way to demonstrate competence of the laboratory

•Accreditation is a tool to recognize laboratories worldwide

•In some countries accreditation is mandatory or will be mandatory in the future

•Accreditation and the linked periodical audits are a stimulant for keeping the quality system alive

•Improve quality of services

•High standard of services for clients – patients, physicians

•Better documentation of processes and responsibilities

7) What do you mean by laboratory accreditation? [2]

=>Laboratory accreditation is a procedure by which an authoritative body gives formal recognition of technical competence for specific tests/ measurements, following international standards.

Accreditation is accomplished through conformity assessment of the laboratory by a competent assessor or team of assessors.

8) Discuss the principle on storage and retention of records in GLP. [2]

=>GLP emphasizes the secure storage and retention of all relevant records, raw data, specimens, and samples. This Practice ensures data integrity, facilitates audit trails, and supports the reproducibility of scientific findings.

9) What is QCI? [2]

=>Quality Council of India (QCI) was set up as a non-profit autonomous society registered under Societies Registration Act XXI of 1860 to establish an accreditation structure in the country. QCI is governed by a Council comprising of 38 members.

10) What are the main functions of QCI? [2]

=>i) To develop, establish & operate National Accreditation programmes for various service sectors such as education, healthcare, environment protection, governance, social sectors, infrastructure sector, vocational training etc., in accordance with the relevant international standards & guides for the conformity assessment bodies certifying products, personnel, management systems, carrying out inspection and for the laboratories undertaking testing & calibration and such other areas of organized activities that have significant bearing in improving the quality of life and well being of the citizens of India.

ii) To develop accreditation standards to support accreditation programs where such standards are not available at the national/international level.

11) Name the accreditation boards under QCI. [2]

=>•National Accreditation Board for Certification Bodies (NABCB)

•National Accreditation Board for testing & calibration Laboratories (NABL)

•National Accreditation Board for Hospitals and healthcare providers (NABH)

•National Accreditation Board for Education & Training (NABET)

12) What is ISO/IEC 17025:2005 and ISO 15189:2007? [2]

=>ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, laboratories methods.

ISO 15189:2007 specifies requirements for quality and competence particular to medical laboratories.

13) Which products are included under the GLP regulations? [2]

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14) Discuss the principle on test facility organization and personnel in GLP. [2]

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15) Discuss any two ethical principles that should be followed by a medical laboratory professional? [2]

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