Compliance

To achieve quality compliance, blood transfusion facilities must maintain Current Good Manufacturing Practices and conform to various FDA, AABB and other regulatory protocols. Satisfactory compliance can be attained by establishing a comprehensive and coordinated approach to total quality management.

• Current Good Manufacturing Practices (cGMPs): the basis for and history of the FDA regulations

• FDA/external inspections: inspection policies, preparing for inspections, risk assessments, inspection do’s and don’ts, corrective action plans, inspection report responses

• AABB and other accreditation assessments: preparation, corrective action plans, assessment report responses

• FDA reporting: biological product deviations, product recalls

• Regulatory guidance: licensure, supplements, amendments, comparability protocols, regulatory enforcement management (warning letter, consent decree)