Compliance, Safety, Integrity of Data
When commissioning a non-clinical health and environmental safety study, sponsors should ensure that the test facility is able to conduct the study in compliance with Good Laboratory Practice (GLP) and ensure that the study is performed under GLP (OECDGLP ENV/MC/CHEM(98)17, Number 11 for “The Role and Responsibilities of the Sponsor in the Application of the Principles of GLP”).
It'sQA provides independent consultancy and pharmaceutical auditing in the area of Good Laboratory Practice, providing assurance of compliance with OECD GLP or/and FDA CFR21, part 58, for Good Laboratory Practice for Nonclinical Laboratory Studies and part 11 for Electronic Records; Electronic Signatures.
It'sQA auditors are qualified and experienced in conducting audits of all facilities, laboratories, and studies in nonclinical research - including the interfaces with GCLP and GMP and the use of computer systems. Not being involved in any other research activity enables It'sQA to conduct truly independent audits with no conflict of interest.
We have experience in most animal modules and analysis laboratories. We can help you develop and deliver a complete audit programme for nonclinical studies or simply help with particular aspects of GLP audits. We can use our auditing SOPs and systems or we can use Sponsors' SOPs and systems to meet each individual client’s needs.
Common audits include:
Assessment audits of CROs and other Vendors – Prequalification
Independent audits of CROs prior to contract placement to give assurance that the organisation is fully compliant with OECDGLP or FDAGLP and able to provide the service required.
Facility Audits – Requalification
Review Test Facility procedures and Studies documentation on in-life study procedures to assure compliance with GLP.
Laboratories Audits - GLP
Review Test Sites analyzing your non-clinical samples (e.g. biochemistry, bioassay, histology, archive) to assure compliance with GLP.
Clinical Laboratories Audits – GCLP
Review Test Sites analyzing your Clinical samples (e.g. biochemistry, bioassay) to assure compliance with Good Clinical Laboratory Practice; GCLP.
Preparation for Regulatory Inspections
OECD National Monitoring Authority carry out inspections in accordance with OECDGLP. Full inspections can be carried out or advice and training of staff provided.
Non-Clinical Report Audits
To provide assurance that the non-clinical study report accurately reports the conduct and results of the study and that the format complies with OECDGLP or FDAGLP.
Gap Analysis to GLP
Let us help you achieve a OECD-GLP first accreditation by performing deep and detailed Gap Analysis, recommendations for corrections and successfully upgrading the company quality to be ready to OECD National Monitoring Authority inspection.
Global nonclinical audits
We have conducted nonclinical audits all over the world including many countries across Europe, Canada, India, Israel, and USA.