Good Clinical Laboratory Practices (GCLP)

By Disu Tajudeen

Laboratories are a fundamental source of scientific evidence critical for clinical and industrial research and decision making in clinical diagnostics, product development and improvement and patient care, and epidemiological responses. High quality laboratory results, from patients, epidemiological survey, clinical trials participants are a key part of the diagnostic, epidemiological response and clinical trial process.

They provide critical data that is used for evidence-based decision making about an investigational medicinal product’s safety, efficacy and mechanism of action, and to improve standard care. This data is also required to protect the health and safety of the patients and the participants involved. Because of this, it is essential that laboratories meet quality and management standards so that the results they produce are unbiased, accurate and complete.

GxP is a general abbreviation for the "good practice" quality guidelines and regulations. The "x" stands for the various fields, including the pharmaceutical and food industries.  

Examples of GxPs include but not limited to

· Good agricultural practice, or GAP

· Good automated laboratory practice, or GALP

· Good automated manufacturing practice, or GAMP

· Good clinical data management practice, or GCDMP

· Good clinical practice, or GCP

· Good cell culture practice, or GCCP

· Good clinical laboratory practice, or GCLP

· Good documentation practice, or GDP, or GDocP (to distinguish from "good distribution practice")

· Good engineering practice, or GEP

· Good hygiene practice, or GHP

· Good horticultural practice, or GHP

· Good laboratory practice, or GLP

· Good microbiological practice, or GMiP

· Good pharmacovigilance practice, or GPvP or even GVP

· Good pharmacy practice, or GPP

· Good policing practice, or GPP

· Good research practice, or GRP

· Good safety practice, or GSP

· Good tissue practice, or GTP

Good Clinical Laboratory Practice guidelines, first described in 2003 by the British Association of Research Quality Assurance (BARQA), were created to bridge the gap between guidelines for good clinical practice (GCP) and good laboratory practice (GLP)

Good Clinical Laboratory Practice (GCLP) is a set of standards that provide guidance on implementing Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) principles to the analysis of samples from a clinical trial. GLP is a quality system that covers the organizational process and the conditions under which non-clinical laboratory studies are planned, performed, monitored, recorded, archived and reported (OECD 1998). This with the aim of promoting the generation of valid, high quality test data.

On the other hand, GCP is an international ethical and scientific quality standard for designing, conducting, performing, monitoring, auditing, recording, analyzing and reporting clinical trials that involve the participation of human subjects. Compliance with this standard provides assurance that the data and reported results are credible and accurate, and that the rights, safety and confidentiality of trial subjects are protected (ICH 1996 GCP Guideline).

By combining the GLP and GCP sets of guidelines, GCLP ensures the quality and reliability of the results and clinical trial data generated by laboratories. Consequently, GCLP is critical for diagnostic and clinical trial laboratory operations and it is expected that compliance with the GCLP standards, monitored annually by external audits, will help laboratories to maintain data integrity, provide safety to the personnel and related environment and produce effective results that are consistent, auditable, and repeatable. 

GCLP provides a bridge between GCP and GLP. It is also a framework in which organizations can base to develop facilities, systems and procedures that guarantee the laboratory work and results fulfil the GLP and GCP expectations.

GCLP encompass all aspects of clinical trial laboratory operations, namely: organization and personnel; facilities; equipment, materials and reagents; standard operating procedures; planning of the work; sub-contracting; trial materials; conduct of work; reporting results; quality control & quality audits; storage and retention of study records and reports; and confidentiality.

 There are many benefits to laboratories that are GCLP compliant, the main benefits include:

· Laboratory results (research or diagnostic) that are reliable, reproducible and auditable

· The incidences of false negatives and false positives are reduced

· Results are assured to be of the highest quality

· Results are comparable to those obtained in other compliant laboratories around the world

· Building the confidence of staff, sponsors and clients

· Resources are efficiently managed therefore minimizing waste

· Uniformity and standardization of systems

· International standards are generally followed and easily achieved ( ISO 15189)