EFGCP Guideline for Auditing Clinical Laboratories - European ...

Guideline for Auditing Clinical Laboratories
Alarms; verify that they are tested
Fire control facilities; fire extinguisher (tested)
Protection from water (look for water pipes in the ceilings of rooms), humidity
Protection from rodents and insects
Protection from theft
Contingency plans for the archive and records of how the staff have been trained to manage
emergencies.
Procedures for the logging in and checking-out and re-logging-in of records.
Provisions for archiving electronic data (including in addition to the above, protection from
electromagnetic radiation).
4 GLP STUDIES
Certain activities e.g. the bioanalytical part in bioequivalence studies, have to be conducted in compliance
with the principles of GLP (CPMP/EWP/QWP/1401/98 Note For Guidance on the Investigation of
Bioavailability and Bioequivalence, Adopted July 2001).
If the laboratory claims to be working in compliance with GLP, the auditor should review the following
additional requirements:
that the sponsor’s name is coded to protect records / data from identification by other sponsors
the audit plan to verify that an appropriate audit program (e.g. study-based, process-based and facilitybased
audits should be performed) covering the studies is in place.
• that a Master Schedule is present and maintained, and able to demonstrate that the Study Director
has the sufficient capacity to fulfil his / her obligations for the study.
• that the Study Director has signed the study plan/protocol.
• the availability of SOPs for handling amendments to, and or deviations from the Study Plan
• that the Study Director and Management at the ‘Testing Facility’ are informed of any deviations.
• that QA verifies the study plans as defined in the SOP.
• that as required by the SOP, the QA unit audits the final reports (audit to confirm that the methods,
procedures and observations are accurately and completely described and that the reported results
accurately and completely reflect the raw data of the studies).
• that the study reports contain QA Statements that list all the audits conducted, when they were
reported to management and how critical findings have been followed-up and resolved.
• that the final report is signed by the Study Director/Principal Investigator and that the report contains a
declaration of responsibility and GLP compliance.
• Verify that the members of staff have been trained in GLP as appropriate.
Furthermore the auditor should:
Verify which inspectorate(s) have conducted inspections and when these have taken place.
Review the certificate and determine the scope and outcome of the inspection.
EFGCP - Clinical Laboratories - Final Version 1.0 Page 14 of 15
2005