Global Pharma QA customizes our audits/consultancy according to your specific needs. Audit plans are developed using a risk based approach that ensure regulatory compliance.
For-cause audits are conducted if there are any concerns regarding possible fraud or possible misconduct or client complain. It is often preferable that an independent auditor conducts these audits, as it promotes impartiality.
We offer the following GLP/GCLP Audits:
Assessment audits of CROs and other Vendors – Prequalification
Independent audits of CROs prior to contract placement to provide assurance that the organization is fully compliant with OECDGLP and/or FDAGLP and is able to provide the service required.
Facility Audits – Re-qualification
Review test facility procedures and studies documentation and critical in-life study procedures to assure compliance with GLP.
Laboratories Audits - GLP
Review the test sites analyzing your non-clinical samples (e.g. biochemistry, bioassay, histology, archive) to assure compliance with GLP.
Clinical Laboratories Audits – GCLP/ISO15189
Review clinical laboratories/reference laboratories analyzing your clinical samples (e.g. biochemistry, bioassay) to assure compliance with Good Clinical Laboratory Practice; GCLP/ISO15189
Non-Regulated / University Labs – Good Practice
Review non-regulated / university labs laboratories analyzing your samples to assure compliance with good practice and reliability of study data.
Non-Clinical Reports Audit and Regulatory Submissions Audit: NDA, IB, IND, Response letters
To provide assurance that the no-clinical/clinical analysis study report accurately reports the conduct and results of the study and that the format complies with GLP. QA Review of GLP/GCLP sections of regulatory submissions.
We can use Global Pharma QA procedures or your SOPs and computerised systems to meet your needs.