As a sponsor any non-clinical lab facility you use to conduct toxicology and safety testing in animals, may be subject to inspections by EPA, FDA, or global other regulatory bodies. CRQA can help you with readinessfor such inspections by performing independent audits of sponsor or contract facilities and studies, giving you added assurance that a lab is in compliance with regulations and SOPs. In case of deficiencies identified during such audits, CRQAteam of auditors can recommend remedial actions. Detailed audit reports are submitted with CAPA.

• Routine and qualification audits of contract laboratories
• Facilities and equipment audit
• Review organizational structure
• Review SOPs
• Review Qualification and training records
• Asses testing facilities operation, including test and control articles
• Review records, reports, and record/sample retention
• Assess data transfer process
• IT and data integrity audit
• Assess quality assurance department

GCLP compliance ensures that the labs have adequate facilities, systems, and procedures to analyse samples from clinical trials and that the results are produced and reported according to the regulations and guidelines. Any organisation that analysed samples collected during the conduct of clinical trials should adopt GCLP standards. Moreover, clinical laboratories who aim to demonstrate to their sponsors of clinical trials and government agencies that they operate in compliance with the ICH GCP standards and applicable regulations for clinical laboratories, should must undergo independent GCLP Laboratory audits.

ICH GCP Guidelines are the primary guidelines for the conduct of clinical trials.However, GCP guidelinesdoes not offer guidance on the process which should be followed when analysing samples for clinical trials. Hence, there are additional guidelines to support clinical labs when handling samples from clinical trials. A most common term used to summarise those guidelines is GCLP(Good clinical Laboratory Practice). GCLP applies the principles of GCP, such as ethics, informed consent, confidentiality or subject safety, but at the same time ensuring the adequate reliability and the integrity of the data generated by the clinical laboratories.

CRQA GCLP audits are planned to cover the facility management, quality management systems, handling analysis and result reporting of samples, data management, IT systems and archiving. CRQA’s highly experienced and qualified auditors and consultants have audited hundreds of laboratories over the years in different countries, and they can provide advice and training to laboratories which need to ensure compliance with the GCLP regulations and guidelines. CRQA can also conducts GCLP Qualification Audits on behalf of sponsors who would like to ensure that the analysis of the clinical samples are conducted according to the global regulations and guidelines.

The reference standards which are followed during GCLP Audits are listed are listed below. CRQA GCLP Auditors will assess compliance with the following guidelines and applicable reference standards:

• ICH GCP (CPMP/ICH/135/95)
• WHO Good Clinical Laboratory Practice (GCLP) 2009
• FDA 21 CFR part 58 Good Laboratory Practice for Nonclinical Laboratory Studies
• FDA Guidance for Industry: Bioanalytical Method Validation (2001 and draft Sep-13)
• FDA Guidance for Industry May 2007: Computerized Systems used in Clinical Investigations
• FDA 21 CFR part 11 Electronic Records, Electronic Signatures
• EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples (28-Feb-12)
• EMA Guideline on Bioanalytical Method Validation, 2012
• EMA Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials, 2010
• EU Directive 2004/9/EC on the inspection and verification of good laboratory practice (GLP), as applicable