The process of converting laboratories into GCLP-compliant entities includes . with GCLP, to describe the relationships between the EQAPOL Management and .. considering ISO/IEC accreditation for the proficiency testing program. Qualogy designed an accreditation scheme to access a laboratories compliance with the standards of GCLP. The Qualogy GCLP accreditation scheme involves. Partnership with the Sponsors – building a strong relationship with the Section Essential Documents -- certification or accreditation or This poster will discuss the GCP requirements for labs, the intent of GCLP, the procedural.
Any deviations from the SOPs were documented on a corrective action preventive action form and signed by the PI.
Article: Laboratory accreditation - Global Health Laboratories
Laboratory Analytical Plans Even though the development of analytical plans as a component of a quality system is one of the items considered difficult to implement in a basic research laboratory, its implementation can be enhanced through flexible routines. GCLP requires that all studies should have a documented laboratory analytical plans.
All the staff from the research groups were trained on writing a laboratory analytical plan by the laboratory quality officer, and an analytical plan template was developed to document all the existing and upcoming studies. The laboratory analytical plans helped in planning the conduct of the research studies and capturing some of the information about the laboratory that is not always indicated in the study protocol.
Copies of approved laboratory analytical plans and protocols were filed in the laboratory for easy accessibility and reference. Assay Optimization and Validation To produce accurate and reliable research data, these procedures need to be validated. Moreover, one of the GCLP requirements is to have all the research procedures validated.
Validated and optimized procedures are easy to transfer from one laboratory to another, as suggested by Ozaki et al. Validation plans that include the selected parameters and a statistical analysis plan were developed and approved by the PIs. Laboratory Quality Management Plan Quality Management is a systematic approach to achieving quality objectives.
It must describe procedures for monitoring, assessment and correction of problems identified in pre-analytical, analytical and post analytical aspects of all lab operations. The QMP should describe the following: In addition, other guidance and accreditation information is presented to augment and clarify GCLP. Participants attending the training will get an understanding of key components of GCLP, and the role they play in assuring the validity of studies. The importance of documentation is stressed throughout the training.
However, it is recommended that laboratory personnel receive training in GCLP. The frequency of this training must be sufficient to ensure that employees remain familiar with the GCLP requirements applicable to them. GCLP compliance will ensure that consistent, reproducible, auditable, and reliable laboratory results that support clinical trials will be produced in an environment conducive to study reconstruction.
These audit report findings must be adequately addressed by the laboratory to maintain a satisfactory performance standard. Instrument and Method Validation DAIDS requires laboratories to perform validation prior to placing a new method or instrument into routine use, whenever the conditions change for which the method has been validated or if the change is outside the original scope of the method.
To minimize validation requirements, the use of FDA-approved methodologies is strongly encouraged. The paper is primarily aimed at contract research organisations, sponsors laboratories and non-commercial laboratories that are involved in the production of data that is used to assess end points of safety and efficacy. The paper is not specifically designed for laboratories that perform routine clinical chemistry or gather data which will be used for purposes not directly linked to the primary objectives of the trial.
However, it should be noted that there is a requirement for all laboratories that perform work in support of clinical trials to implement appropriate measures to assure the quality and integrity of the data they produce and to exercise due diligence to ensure that the trial subjects rights are not compromised. This reflection paper is designed to complement existing quality systems where they exist.
GCLP Accreditation | Research Quality Association | RQA
Inspectors are encouraged to consider the scope and focus of existing quality systems before performing a laboratory inspection in order to avoid duplication of effort. The reflection paper is also applicable to investigator initiated trials. This can be found on the EMA website: