Bioequivalence Study File Retention
Based on the regulatory framework governing laboratory testing and documentation, bioequivalence study files must be retained for a minimum of 2 years after approval, though longer retention periods may be required depending on jurisdiction-specific regulations.
Regulatory Requirements for Record Retention
The Clinical Laboratory Improvement Amendments (CLIA) establishes the baseline standard for laboratory record retention:
CLIA mandates that laboratories retain records of patient testing, including test requests and authorizations, test procedures, analytic systems records, records of test system performance specifications, proficiency testing records, and quality system assessment records, for a minimum of 2 years 1, 2.
Test reports must be retained for at least 2 years after the date of reporting 1.
Important Caveats and Considerations
Jurisdiction-Specific Requirements
Retention policies and procedures must comply with applicable state laws and other requirements (e.g., of accrediting organizations if the laboratory is accredited) 1.
If state regulations require longer retention periods, laboratories must comply with the more stringent requirement 1.
Extended Retention for Quality Management
Laboratories may retain records for longer periods for quality management purposes 1.
Primary data from which reports are generated should be kept along with the reports, preferably electronically 1, 2.
Electronic Record Considerations
- Laboratories must ensure that electronic records remain accessible as electronic storage technology continues to evolve 1, 2.
Answer to the Multiple Choice Question
The correct answer is B) Five years, as this represents a common regulatory standard that exceeds the minimum 2-year CLIA requirement and aligns with typical pharmaceutical industry practices for maintaining documentation related to drug approval processes, though the specific requirement depends on the governing regulatory authority's jurisdiction.