The Quality Compliance Unit is a part of the Cincinnati Children's Office of Research Compliance and Regulatory Affairs (ORCRA). Quality compliance personnel are responsible for quality assurance within the Translational Core Laboratories to provide regulatory and quality direction and support. ORCRA ensures that each compliance unit has a reporting mechanism that is separate from the area being monitored.
Quality compliance responsibilities:
- GMP & GTP training
- Compliance audits
- Review and approval of critical documents
- Raw material and final product disposition
- Label and batch record issuance and review
- Investigation of complaints
- Supplier qualification
- Administration of the deviation, document control, change control, complaint and annual review systems
- Facility Registration & Core Deviation Reporting
- Operational and facility oversight
Quality compliance staff have provided consultation services and training to various academic and industry sponsors on GLP study design, biorepository requirements, GMP requirements, and cleanroom design, control and validation.