What Are Good Clinical Laboratory Practices?
With a gap left between the Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) guidelines, Good Clinical Laboratory Practice (GCLP) guidelines were established to address both GCP and GLP principles in the analysis of laboratory samples from human clinical trials.
This important bridge between GCP and GLP has set a unified standard that ensures laboratory-generated clinical trial data is high-quality and reliable. When labs adhere to GCLP guidance, they can ensure:
- IND sponsor requirements are met
- A high level of data integrity
- The ability to accurately reconstruct experiments
- Accurate test result comparisons across locations
Closely following GCLP guidance is especially critical when conducting clinical trials involving multiple international laboratory sites.
What GCLP Is:
Part of the overall process for regulatory compliance. These guidelines are intended to ensure the consistency, quality, and integrity of data, assure sponsors and regulatory agencies that all data submitted are a true reflection of the results obtained, and confirm that this data can be relied upon when making risk or safety assessments.
In most cases, clinical trial data is largely laboratory-based and includes study endpoints and participant safety data. If this laboratory data is called into question due to inconsistent practices, an entire trial effort could be jeopardized.
A collection of standards. The GCLP guidance includes standards from other organizations and accrediting bodies, including the College of American Pathologists (CAP) and the International Organization for Standardization (ISO).
By recognizing these standards as the minimum requirements for laboratory operations, GCLP compliance will ensure consistent, reproducible, auditable, and reliable laboratory results.
What GCLP Is Not:
A regulatory requirement. While there is no individual regulation that mandates and describes GCLP, there are several widely acknowledged industry guidelines that describe and assist with the implementation of GCLP.
A one-size-fits-all approach. We know that GCP alone does not define laboratory analysis requirements and GLP focuses on animal testing. The combination of GCP and GLP principles into GCLP offers guidance to ensure the quality and reliability of human clinical trial analysis data.
GCLP compliance is a positive factor for many stakeholders in the pharmaceutical industry. Regulators who are satisfied with GCLP compliance often have a higher probability of drug approval, meaning more sick people become healthier, drug researchers become successful, pharmaceutical organizations become stronger, and stockholders become wealthier. Everybody wins.
Good Clinical Laboratory Practice Core Elements
GCLP core elements include organization and personnel, laboratory equipment, testing facility operations, quality control program, verification of performance specifications, records and reports, physical facilities, specimen transport and management, personnel safety, laboratory information systems, and quality management.
As a result of this core infrastructure, labs produce clinical trial data in an environment conducive to study reconstruction, enable prioritization between candidate product regimens, and guide rational decision making for moving products forward into advanced clinical trials.
Learn more about each of the GCLP core elements below.
Organization and Personnel
Appropriately trained and well-organized laboratory staff are key to the successful operation of a research facility. Systems are required to drive organizational structure, training, and ongoing competency assessment to ensure appropriate accountability and communication during studies.
Proper maintenance of all laboratory equipment is necessary for assays to function within the manufacturer’s specifications. Internal preventative maintenance activities and vendor-provided maintenance and repair for laboratory equipment are paramount in providing accurate and reliable results.
Test Facility Operations
Standard operating procedures (SOPs) are critical for maintaining consistent test performance. The laboratory must write SOPs for all laboratory activities to ensure the consistency, quality, and integrity of the generated data. Current SOPs must be readily available in work areas and accessible to testing personnel.
Quality Control Program
The laboratory director or designee should be actively involved in the design, implementation, and oversight of a site-specific, written quality control program that defines procedures for monitoring analytic performance and consistent identification, documentation, and resolution of QC issues.
The QC program supports functions in the following areas: test standards and controls, reagents, test specimens, review of quality control data, quality control logs, labeling of quality control materials and reagents, inventory control, parallel testing, and water quality testing.
Individual assay controls must be in place to ensure assay performance. Control activities must be well-defined and managed through an ongoing QC program to capture immediate performance issues and assay problems over time. These programs should be involved with both quantitative and qualitative tests.
Verification of Performance Specifications
Validation of manufacturer-provided performance specifications, or the development of such specifications, can be challenging. The assay development and approval status define what parameters are required in a formal validation study. Some guidance on the standards of validating an assay are accuracy, precision, analytical sensitivity, analytical specificity, reportable range, reference intervals, and any other parameter required for test performance.
Records and Reports
The laboratory must define and maintain a system to provide and retain all clinical trial data records and reports for a period of time to troubleshoot potential problems or reconstruct the study for auditing purposes. These records may include specimen tracking forms, laboratory requisitions, chain-of-custody documents, laboratory reports, equipment service and maintenance records, and instrument printouts.
The environment in which laboratory testing is performed must be conducive to efficient operations that do not compromise the safety of the staff or the quality of the pre-analytical, analytical, and post-analytical processes.
Specimen Transport and Management
The accuracy of all laboratory test results depends on the identity and integrity of the specimen submitted. The establishment of a sound specimen chain of custody from collection through reporting test results is paramount in ensuring quality data. The laboratory must have documented procedures for collecting, transporting, and receiving specimens because the accuracy of all laboratory tests depends on specimen quality.
Although exposures and accidents cannot always be avoided, every precaution must be taken to provide a safe work environment for laboratory staff, including a Standard Precautions/Universal Precautions Policy, Chemical Hygiene/Hazard Communication Plan, Waste Management Policy, Safety Equipment, and general safety policies.
Laboratory Information Systems (LIS)
A LIS is a powerful tool for managing complex processes, ensuring regulatory compliance, and promoting collaborations between multiple laboratories. Usually, a LIS is capable of consolidating disparate scientific processes into a single, compliant platform with comprehensive reporting, surveillance, and networking capabilities. The result is vastly enhanced data management and data sharing within the laboratory and across laboratories.
An overarching quality management program is essential to ensure study participants’ safety and the maintenance of quality laboratory operations. The QM program is a systematic approach to plan the achievement of quality objectives, comply with approved procedures, and assign specific functional responsibilities to laboratory staff. The QM program should also include an External Quality Assurance (EQA) program, which is set up to externally evaluate the laboratory’s analytical performance by comparing performance using coded reagent panels with peer laboratories.
Use GCLP Guidance to Prepare for an FDA Audit
Most regulatory bodies have reached a consensus that GCLP compliance is the minimal requirement clinical laboratories should meet to increase adherence to standardized practices and procedures, optimize management operations of clinical laboratories, and enhance obtaining reproducible and reliable results — all while ensuring the safety of human research participants.
The GCLP element regarding clinical laboratory accreditation for GCLP compliance remains open. At present, there is no international, universal, and publicly available accrediting organization acceptable to all parties involved in clinical trials worldwide. With time, and as the GCLP standard becomes globally accepted, GCLP accreditation will find a place in the implementation of GCLP for laboratories.
ICQ utilizes GCLP process flow to prepare pharmaceutical companies and laboratories for potential FDA audits. Could your laboratory benefit from a consistent and standard set of guidelines?