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 conducted by QC2 either in conjunction with a full toxicology facility audit or as a stand-alone audit at a contracted vendor. These audits aim 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, and the International Conference on Harmonisation M10 Guideline: Bioanalytical Method Validation and Study Sample Analysis (May 2022).
Pathology Evaluation Audits including Contracted Reading Vendor Audits
QC2 conducts pathology evaluation audits including 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.
