GLP Audits

QC2 offers the following GLP audits:

Toxicology Facility and Study Audits

QC2 conducts audits of toxicology laboratories to assess systems and facilities for compliance with the study protocol (if applicable), 21 CFR Parts 58 and 11, SOPs, and applicable FDA guidances.  Studies frequently audited by QC2 include general mammalian toxicology (all common species), genetic toxicology, Developmental and Reproductive Toxicology (DART), and Absorption, Distribution, Metabolism, and Excretion (ADME).  QC2 is also able to audit Principal Investigators at Sponsor or Sponsor-designated Test Sites for qualification and/or review of study data.

Formulation Analysis and Bioanalysis Audits

Audits of GLP analytical and bioanalytical laboratories can be performed by QC2 in conjunction with a full toxicology facility audit or as a stand-alone audit at a contracted vendor to assess systems and facilities for compliance with study formulation, pharmacokinetic (PK) and toxicokinetic (TK) requirements, 21 CFR Parts 11 and 58, Standard Operating Procedures, the FDA Guidance For Industry: Bioanalytical Method Validation, May 2001, as well as the EMA Guideline on Bioanalytical Method Validation, February 2012, as applicable.

Pathology Evaluation Audits including Contracted Reading Vendor Audits

Pathology Evaluation Audits include audits of internal and external GLP Pathology Evaluation reports and data to assess systems and facilities for compliance with the study protocol, 21 CFR Parts 58 and 11, SOPs, and applicable FDA guidances.   Similarly, contracted reading vendors performing MRI, X-ray, or echocardiogram interpretation are audited to assess compliance with the study protocol, 21 CFR Parts 58 and 11, SOPs, and applicable FDA guidances.

QC2 audits are customized for your specific project and budget needs.  We can provide assistance with all aspects of your audit projects, including audit plan consulting and development; scheduling, conducting, and reporting on audits; and providing audit follow-up services, including review of audit responses.  We can conduct both general qualification audits and in-study audits.